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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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NATtrol™ BV Positive Control (NATBVPOS-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 Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence 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 Positive Control
Not in Commercial Distribution

  • 01220000260238 ()
NATBVPOS-BD

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
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 with LED (#11820-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

  • 00732094201802 ()
77792-2MPL

  • Aneroid manual sphygmomanometer
IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The 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, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Philips Healthcare Informatics, Inc.
IntelliSpace PACS - 4
In Commercial Distribution

  • 00884838074781 ()
837507

  • Radiology picture archiving and communication system workstation
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSPACS6PRU11B0 ()
PSPACS6PRU11B

  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Connex ProBP 3400 Digital Blood Pressure Device with SureBP (#34XFWT-B), 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

  • 00732094066746 ()
77791-MXPROBP

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259780 ()
XSCRIBE-6CC-CEAAX

  • 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; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259636 ()
XSCRIBE-6CC-DEBAX

  • 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259612 ()
XSCRIBE-6CC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer
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; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259407 ()
XSCRIBE-6DC-DEBAX

  • 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 and RScribe with Interpretation; 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

  • 00732094259162 ()
XSCRIBE-6GC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer
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