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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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twiist - 00850017421479

twiist Replacement Pump Kit
SEQUEL MED TECH, LLC
DKPI-11098-001
In Commercial Distribution

  • 00850017421479 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00850017421448

twiist Disposable Cassette Pack (Sterile)
SEQUEL MED TECH, LLC
DKPI-11099-001
In Commercial Distribution

  • 00850017421431 ()
  • 00850017421448 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00850017421431

twiist Disposable Cassette
SEQUEL MED TECH, LLC
DKPI-11073-001
In Commercial Distribution

  • 00850017421431 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00850017421424

twiist Pump Starter Kit
SEQUEL MED TECH, LLC
DKPI-11029-007
In Commercial Distribution

  • 00850017421424 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00850017421400

twiist Pump Assembly, Labeled
SEQUEL MED TECH, LLC
DKPI-21073-007
In Commercial Distribution

  • 00850017421400 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

SYSTEMS INTEGRATION ENDOALPHA - 04953170435201

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2528
In Commercial Distribution

  • 04953170435201 ()


  • Operating room audiovisual data/device management system application software

UCES-4 Upgrade Pack 2 - 04953170406461

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2370
In Commercial Distribution

  • 04953170406461 ()


  • Operating room audiovisual data/device management system application software

UPGRADE KIT FOR UCES-3 (Version 7) - 04953170390616

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2258
Not in Commercial Distribution

  • 04953170390616 ()


  • Operating room audiovisual data/device management system application software

UPGRADE KIT FOR UCES-3 (Version 6) - 04953170363016

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2139
Not in Commercial Distribution

  • 04953170363016 ()


  • Operating room audiovisual data/device management system application software

BioPlex® 2200 - 00847865001281

U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 00847865001281 ()

  • 1 Each
665-3465A

  • Laboratory instrument/analyser application software IVD
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