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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 - 00198617901008

twiist Refill Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
RF-90100
In Commercial Distribution

  • 00198617901008 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

twiist - 00198617101002

twiist Convenience Starter Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
CM-10100
In Commercial Distribution

  • 00198617101002 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

My Dose Coach - 04030685900001

No Description
Sanofi-Aventis Deutschland GmbH
1.x.x
Not in Commercial Distribution

  • 04030685900001 ()


  • Clinical management support software

LIFECODES MATCH IT! Antibody Software - 10888234500810

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution

  • 10888234500810 ()
888627

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740161316

ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K50-07
In Commercial Distribution

  • 00380740161316 ()
08K5007

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160791

Alinity c Iron Assay File
Abbott GmbH
08P391B
In Commercial Distribution

  • 00380740160791 ()
08P391B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160784

Alinity c MagnesiumU Assay File
Abbott GmbH
08P193B
In Commercial Distribution

  • 00380740160784 ()
08P193B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160777

Alinity c Magnesium Assay File
Abbott GmbH
08P191B
In Commercial Distribution

  • 00380740160777 ()
08P191B

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740157067

ARCHITECT i1000sr System e-Assay CD ROM
ABBOTT LABORATORIES
4P57-22
Not in Commercial Distribution

  • 00380740157067 ()
04P5722

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740157050

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-19
Not in Commercial Distribution

  • 00380740157050 ()
04P5519

  • Laboratory instrument/analyser application software IVD
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