Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.2
In Commercial Distribution

  • 00884838093997 ()
45980163324X

  • Radiology picture archiving and communication system workstation
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution

  • 00884838087958 ()
45980141116X

  • Radiology picture archiving and communication system workstation
NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ BV Negative Control
Not in Commercial Distribution

  • 01220000260245 ()
NATBVNEG-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)
EL.EN. SPA
M133A1
In Commercial Distribution

  • 08057017760665 ()
M133A1

  • General/multiple surgical diode/carbon dioxide laser system
CSPOLA600F is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600F can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600F is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600F
In Commercial Distribution

  • 08800074500305 ()
CSPOLA600F

  • Visual acuity light box
CSPOLA600C is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600C can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600C is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600C
In Commercial Distribution

  • 08800074500299 ()
CSPOLA600C

  • Visual acuity light box
CS550 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CS550 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CS550 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CS550
In Commercial Distribution

  • 08800074500282 ()
CS550

  • Visual acuity light box
PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
PROVUE
In Commercial Distribution

  • 08800074500152 ()
PROVUE

  • Visual acuity light box
CSPOLA600 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600
In Commercial Distribution

  • 08800074500114 ()
CSPOLA600

  • Visual acuity light box
VLC-2400P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400P
In Commercial Distribution

  • 08800074500039 ()
VLC-2400P

  • Visual acuity light box
VLC-2400 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-2400
In Commercial Distribution

  • 08800074500022 ()
VLC-2400

  • Visual acuity light box
VLC-1900P is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900P
In Commercial Distribution

  • 08800074500015 ()
VLC-1900P

  • Visual acuity light box
VLC-1900 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-1900 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
VLC-1900
In Commercial Distribution

  • 08800074500008 ()
VLC-1900

  • Visual acuity light box
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), SureColor LED Lamp Technology, KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066784 ()
77791-MXLED

  • Patient monitoring system module, electrocardiographic
Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in /86.4 x 30.5
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094067811 ()
76797-2PX

  • Blood pressure cuff, reusable
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066760 ()
77791-MXNOBP

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (# 11720), MacroView Otoscope with Throat Illuminator (#23820), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066265 ()
77796-M

  • Aneroid manual sphygmomanometer
The Latitude Style Foot Platform assembly is designed for use with Motion Concepts Power Elevating Calf Panel. The latitude-style foot platform is available with an optional padded foam cover (in standard black Polyester fabric or Onyx (faux-vinyl) fabric), or may be order without a pad.
Motion Concepts Inc
D-0197-LSF
In Commercial Distribution

  • 07540147002299 ()
LSF

  • Wheelchair footrest/legrest
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
Philips Healthcare Informatics, Inc.
IntelliSpace Radiology - 4
In Commercial Distribution

  • 00884838091740 ()
836344

  • Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution

  • 00884838074743 ()


  • Radiology picture archiving and communication system workstation
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121315 ()
77781-MX

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope (#11810), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC P
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094067019 ()
77791-1MPX

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Pl
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066807 ()
77791-MX

  • Aneroid manual sphygmomanometer
Planmeca Compact i is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface which is either a touch panel or a traditional keyboard. The instrument console includes five instrument locations, with easy instrument change.
Planmeca Oy
i
In Commercial Distribution

  • 06430035420438 ()
10031950, 10031951, 10031952, 10031953, 10039745, 10031954, 10031955

  • Dental delivery system
The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.
Luminex Molecular Diagnostics, Inc
I046B0427
In Commercial Distribution

  • 00840487100172 ()
I046B0427

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope with LED (#11720-L), MacroView Otoscope with LED (#23810-L), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094201796 ()
77792-ML

  • Noninvasive device battery charger
Panther Fusion® Extraction Reagents-S.
Hologic, Inc.
KIT, EXTRACTION REAGENTS - S, FUSION, IVD
In Commercial Distribution

  • 15420045509214 ()
PRD-04331

  • Nucleic acid technique (NAT) kit IVD
NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
ZEPTOMETRIX CORPORATION
NATtrol™ Candida/TV Positive Control
Not in Commercial Distribution

  • 01220000260252 ()
NATCTVPOS-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "
Reina Imaging
P[2][X]DR[NG][Y]
In Commercial Distribution

  • 00860001700183 ()
Premium Grid Encasement

  • Stationary x-ray grid
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (40 x 12 in / 101.6 x 30.5 cm), Short Power Cord (18 in/45.7 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121292 ()
77782-16M

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Vital Signs Device (order device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-24
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094121254 ()
77794-2MPSPOT

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066715 ()
77792-2MP

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Lxi Vital Signs Device (order device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 10
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094066487 ()
77794-2MPLXI

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Lxi Vital Signs Device (order device separately), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066456 ()
77794-MLXI

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Mounting Screws for Spot Vital Signs Device (order device separately), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066432 ()
77794-MSPOT

  • Aneroid manual sphygmomanometer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), Pneumatic Otoscope (#20201), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066043 ()
77797-X

  • Aneroid manual sphygmomanometer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307085 ()
XSCRIBE-6DC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259605 ()
XSCRIBE-6CC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), Coaxial Ophthalmoscope (#11720), MacroView Otoscope with Throat Illuminator (#23820), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094066401 ()
77795-MX

  • Aneroid manual sphygmomanometer
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
SMART MEDICAL SYSTEMS LTD
SPARKC
In Commercial Distribution

  • 07290018671504 ()
40-016

  • Catheter/overtube balloon inflator, reusable
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