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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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BD BBL™ Sensi-Disc™ 6-Place Self-Tamping Dispenser
BECTON, DICKINSON AND COMPANY
260661
In Commercial Distribution

  • 00382902606611 ()
260661

  • Antimicrobial sensitivity disc dispenser IVD
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
BD MAX UVE Specimen Collection Kit
BECTON, DICKINSON AND COMPANY
443376
Not in Commercial Distribution

  • 30382904433766 ()
  • 00382904433765 ()
443376

  • Urogenital specimen collection kit IVD, clinical
  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
CONSOLE 106A3 GEN V ROHS PLX
Medtronic CryoCath LP
106A3
In Commercial Distribution

  • 00763000486778 ()


  • Cardiac cryosurgical system
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
GAMBRO DASCO SPA
6023006700
Not in Commercial Distribution

  • 07332414042035 ()
103453

  • Haemodialysis system dialysate delivery unit
CONSOLE 106A3 GEN V ROHS PLX
MEDTRONIC, INC.
106A3
In Commercial Distribution

  • 00763000011147 ()


  • Cardiac cryosurgical system
BLOOD CULTURE, TUBE HOLDER
MEDLINE INDUSTRIES, INC.
BCTHLDR
In Commercial Distribution

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

  • Blood collection set, invasive
DreamStation BiPAP Pro with Humidifier and Cellular, USA
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, US
In Commercial Distribution

  • 00606959025660 ()
DSX600H11C

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier and Cellular Modem, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, AHP
Not in Commercial Distribution

  • 00606959025516 ()
AHX600H11C

  • Home BPAP unit
REMstar SE with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020078 ()
CA221HS

  • Heated respiratory humidifier
  • Home CPAP unit
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