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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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CAPILLARYS/MINICAP WASH SOLUTION (2) - 03607360020524

CAPILLARYS /MINICAP WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085.
SEBIA
2052
In Commercial Distribution

  • 03607360020524 ()
2052

  • Wash/cleaning solution IVD, automated/semi-automated system

CAPILLARYS CDT MAXI KIT - 03607360020296

CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
SEBIA
2029
In Commercial Distribution

  • 03607360020296 ()
2029

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

CAPILLARYS CDT - 03607360020098

CARBOHYDRATE DEF TRANSFERRING BY CE
SEBIA
2009
In Commercial Distribution

  • 03607360020098 ()
2009

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

CAPILLARYS PROTEINE 6 - 03607360020036

PROTEIN SEPARATION USING CAPILLARY ELECTROPHORESIS
SEBIA
2003
In Commercial Distribution

  • 03607360020036 ()
2003

  • Protein electrophoresis IVD, kit, electrophoresis

Integra® Miltex® - 10381780171898

Integra® Miltex® CryoSolutions® Complete Set, 1mm Standard Tip(33511), 1 Cartridge(33518)(23.5g N2O) and 1 Metal Pin(33520)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
33510
In Commercial Distribution

  • H834335101 ()
  • 10381780171898 ()
33510

  • General cryosurgical system, cryogen gas, mechanical

NA - 00763000486778

CONSOLE 106A3 GEN V ROHS PLX
Medtronic CryoCath LP
106A3
In Commercial Distribution

  • 00763000486778 ()


  • Cardiac cryosurgical system

NA - 00763000011147

CONSOLE 106A3 GEN V ROHS PLX
MEDTRONIC, INC.
106A3
In Commercial Distribution

  • 00763000011147 ()


  • Cardiac cryosurgical system

MEDLINE - 20193489189664

BLOOD CULTURE, TUBE HOLDER
MEDLINE INDUSTRIES, INC.
BCTHLDR
In Commercial Distribution

  • 30193489189661 ()
  • 20193489189664 ()
  • 10193489189667 ()
BCTHLDR

  • Blood collection set, invasive

JOBST Elvarex - 04019702303100

Elvarex 2/Glove to elbow/With Finger, with Thumb/Slip form with volant
BSN-Jobst GmbH
77359-00007-00
In Commercial Distribution

  • 04019702303100 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

DreamStation BiPAP AVAPS - 00606959045774

DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU
In Commercial Distribution

  • 00606959045774 ()
AUX1131T15C

  • Portable electric ventilator
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