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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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Tandem Mobi - 00389152075013

Tandem Mobi Pump with Control-IQ
Tandem Diabetes Care, Inc.
1010750
In Commercial Distribution

  • 00389152075013 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Dorma - 00606959007413

Dorma 200 with Humidifier, USA
Respironics, Inc.
Dorma 200, with Humidifier, US
In Commercial Distribution

  • 00606959007413 ()
DSV200H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma - 00606959006942

Dorma 100 with Humidifier, LA
Respironics, Inc.
Dorma 100 with Humidifier, LA
In Commercial Distribution

  • 00606959006942 ()
LAV101H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma - 00606959006928

Dorma 100 with Humidifier, International
Respironics, Inc.
Dorma 100 with Humidifier, INTL
In Commercial Distribution

  • 00606959006928 ()
INV101H

  • Heated respiratory humidifier
  • Home CPAP unit

Performatrak - 00606959003279

PERFORMATRAK FULL with CAPSTRAP, SMALL
Respironics, Inc.
PERFORMATRAK FULL w CAPSTRAP,SMALL
In Commercial Distribution

  • 30606959003270 ()
  • 00606959003279 ()
1041494

  • CPAP/BPAP face mask, single-use

Tissue-Tek® Glas™ g2 - 00615233080776

Glass Coverslipper with Barcode System
SAKURA FINETEK U.S.A., INC.
6503
In Commercial Distribution

  • 00615233080776 ()
6503

  • Barcode reader
  • Microscope slide coverslipper IVD

Tissue-Tek® - 00615233078599

Staining Dish, White with lid
SAKURA FINETEK U.S.A., INC.
4457
In Commercial Distribution

  • 00615233078599 ()
4457

  • Assay container IVD, reusable

CARDINAL HEALTH - 10888439536881

C SECTION WITH BASIN PACK
Cardinal Health 200, LLC
SMAOCCSWYJ
In Commercial Distribution

  • 50888439536889 ()
  • 10888439536881 ()
SMAOCCSWYJ

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439527438

CATARACT PACK WITH NO TUBING
Cardinal Health 200, LLC
SEY4FCNUC4
In Commercial Distribution

  • 50888439527436 ()
  • 10888439527438 ()
SEY4FCNUC4

  • Ophthalmic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10888439266139

CATH LAB PACK WITH NAMIC
Cardinal Health 200, LLC
SANOCCLSF8
In Commercial Distribution

  • 50888439266137 ()
  • 10888439266139 ()
SANOCCLSF8

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
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