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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AVEA NIMV+VG SW KEY
Carefusion Corporation
63865
Not in Commercial Distribution

  • 10846446017564 ()


  • Ventilator application software
KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software
AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution

  • 10190752175921 ()
63865

  • Ventilator application software
The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS8000
In Commercial Distribution

  • 00849811060991 ()
AS8000

  • Magnetic particle separation instrument IVD
The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS6000
In Commercial Distribution

  • 00849811051340 ()
AS6000

  • Magnetic particle separation instrument IVD
No Description
HANWOOLTPC Co., Ltd.
NC-15PLUS(48)
In Commercial Distribution

  • 08809886490019 ()


  • Magnetic particle separation instrument IVD
No Description
HANWOOLTPC Co., Ltd.
NC-15PLUS(32)
In Commercial Distribution

  • 08809886490002 ()


  • Magnetic particle separation instrument IVD
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
T2 BIOSYSTEMS, INC.
70-04933
In Commercial Distribution

  • M70870049330 ()


  • Magnetic particle separation instrument IVD
ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software
RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software
RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software
RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution

  • 00619498313334 ()
31333

  • Ventilator application software
RESSCAN V 5.9 CD ASSY
RESMED PTY LTD
31332
In Commercial Distribution

  • 00619498313327 ()
31332

  • Ventilator application software
RESSCAN V 5.8 CD ASSY
RESMED PTY LTD
31330
In Commercial Distribution

  • 00619498313303 ()
31330

  • Ventilator application software
RESSCAN V 5.7 CD ASSY
RESMED PTY LTD
31329
In Commercial Distribution

  • 00619498313297 ()
31329

  • Ventilator application software
RESSCAN V 5.5 CD ASSY
RESMED PTY LTD
31327
In Commercial Distribution

  • 00619498313273 ()
31327

  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software
EasyCare Tx V9.0 CD ASSY
RESMED PTY LTD
25945
In Commercial Distribution

  • 00619498259458 ()
25945

  • Ventilator application software
EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution

  • 00619498259441 ()
25944

  • Ventilator application software
RESSCAN DATA CARD MODULE
RESMED PTY LTD
22915
In Commercial Distribution

  • 00619498229154 ()
22915

  • Ventilator application software
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
AIRVIEW
RESMED PTY LTD
22240
In Commercial Distribution

  • 00619498222407 ()
22240

  • Ventilator application software
RESSCAN DATA CARD READER
RESMED PTY LTD
22207
In Commercial Distribution

  • 00619498222070 ()
22207

  • Ventilator application software
AirView
RESMED PTY LTD
4.2
In Commercial Distribution

  • 00619498000845 ()


  • Ventilator application software
RESSCAN USB ADAPTER
RESMED PTY LTD
22203
In Commercial Distribution

  • 00619498222032 ()
22203

  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software
MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes. Product Use Limitations: The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.
CHROMA ATE INC.
MagXtract 3200
In Commercial Distribution

  • 04719889100010 ()


  • Magnetic particle separation instrument IVD
iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software
End Tidal CO2 Monitoring Option For 980 Series Ventilator
Covidien LP
10084332
In Commercial Distribution

  • 30884521252954 ()


  • Ventilator application software
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-NPure32
In Commercial Distribution

  • 06974849369052 ()


  • Magnetic particle separation instrument IVD
No Description
HANGZHOU ALLSHENG INSTRUMENTS CO.,LTD.
Auto-Pure 2400
In Commercial Distribution

  • 06975141982055 ()


  • Magnetic particle separation instrument IVD
Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient.
Circassia AB
VERO Filter
In Commercial Distribution

  • 07350047030496 ()
  • 7350047030489 ()
  • 7350047030502 ()
  • 07350047030199 ()
12-1018

  • Pulmonary function testing filter/mouthpiece
No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software
Blood Oxygen Cable/Nellcor-Oximax/3.0M/097+170/Nellcor/NEW Partssource
Unimed Medical Supplies, Inc.
U710-70P(NPS)
In Commercial Distribution

  • 06936735450497 ()


  • Electrical-only medical device connection cable, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN SINGLE TUBE
KENTRON HEALTHCARE, INC.
177706S
In Commercial Distribution

  • 00851785007889 ()
177706S

  • Blood pressure cuff, reusable
New handle, Alligator, without spike, Two Wire, 2.2*2300 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10022230
In Commercial Distribution

  • 16932503540671 ()
  • 06932503540674 ()
  • 26932503540678 ()
  • 36932503540675 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 230 Centimeter


  • Flexible endoscopic biopsy forceps, single-use
New handle, Alligator, without spike, Two Wire, 2.2*1800 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10022180
In Commercial Distribution

  • 16932503540664 ()
  • 06932503540667 ()
  • 26932503540661 ()
  • 36932503540668 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 180 Centimeter


  • Flexible endoscopic biopsy forceps, single-use
New handle, Alligator, with spike, Two Wire, 2.2*2300 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10122230
In Commercial Distribution

  • 16932503540657 ()
  • 06932503540650 ()
  • 26932503540654 ()
  • 36932503540651 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 230 Centimeter


  • Flexible endoscopic biopsy forceps, single-use
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177806D
In Commercial Distribution

  • 00866512000262 ()
177806D

  • Blood pressure cuff, reusable
Abutment New Engaging H 3.0 for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Engaging H 3.0 for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022176 ()
EVA154C:

  • Dental implant system
Abutment New Engaging H 1.5 for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Engaging H 1.5 for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022152 ()
EVA152C:

  • Dental implant system
NEW JERSEY Brain Retractor, self-retaining, 6", (150 mm), non-sterile, reusable
Aesculap AG
FF431R
In Commercial Distribution

  • 04038653065554 ()
FF431R

  • Surgical retractor/retraction system blade, reusable
Power Cord UK/Australia/New Zealand For use with IABP
TELEFLEX INCORPORATED
IPN927598
In Commercial Distribution

  • 10801902214352 ()
IAA-09695

  • Intra-aortic balloon pump
New Orleans Needle Holder 7" (17.5cm), serrated jaws, tungsten carbide
Hayden Medical, Inc.
520-472
In Commercial Distribution

  • 00840319752050 ()
520-472

  • Suturing needle holder, reusable
3 Lead Grouped NK to Pinch, 29" AHA New Gen.
GRAPHIC CONTROLS ACQUISITION CORP
LWG-3810029/3A
In Commercial Distribution

  • 00009336005024 ()
LWG-3810029/3A

  • Electrocardiographic lead set, reusable
Patient RoomLifts Product Description: Patient Lift,New Style,1/cs
Drive Devilbiss Healthcare
13023
Not in Commercial Distribution

  • 00822383103297 ()


  • Mobile patient lifting system, electrically-powered
PUNCH FOR NASAL HOOD CAPNOGRAPHY KIT SS NEW 9/2013
ACE SURGICAL SUPPLY CO., INC.
9600456
In Commercial Distribution

  • 00614950024476 ()
9600456

  • Skin-coring punch, reusable
Glove, Exam, Vinyl, NEW AGE® Synthetic +, Powder-Free, Latex-Free, Extra-Large
TRONEX INTERNATIONAL, INC.
7945-35
In Commercial Distribution

  • 00097604794541 ()
  • 10097604794548 ()


  • Vinyl examination/treatment glove, non-powdered
Glove, Exam, Vinyl, NEW AGE® Synthetic +, Powder-Free, Latex-Free, Large
TRONEX INTERNATIONAL, INC.
7945-30
In Commercial Distribution

  • 00097604794534 ()
  • 10097604794531 ()


  • Vinyl examination/treatment glove, non-powdered
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