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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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None - 00886874125939

Blue System Cable, Type B, 7m
INTUITIVE SURGICAL, INC.
399202
In Commercial Distribution

  • 00886874125939 ()


  • Electrical-only medical device connection cable, reusable

CARDINAL HEALTH - 10198956089570

KIT, OPEN HEART A, B, C
Cardinal Health 200, LLC
PV69HEECG
In Commercial Distribution

  • 50198956089578 ()
  • 10198956089570 ()
PV69HEECG

  • Cardiothoracic surgical procedure kit, medicated, single-use

Serial Data Com. Cable Recording-/CARTO® Systems - 04260166371499

No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable

SpO2.COM™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult/neonatal SpO2 disposable sensor - 10843997000496

No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use

SpO2.COM® RS-1 adult SpO2 reusable sensor - 00843997000505

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

Procleix Parasite Transport Medium - 00859882007757

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Lysis Buffer
In Commercial Distribution

  • 00859882007757 ()


  • Blood cell lysis reagent IVD

Procleix Babesia Assay - 00859882007740

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Calibrators
In Commercial Distribution

  • 00859882007740 ()


  • Babesia microti nucleic acid IVD, calibrator

Procleix Babesia Assay - 00859882007733

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Box 3
In Commercial Distribution

  • 00859882007733 ()


  • Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Babesia Assay - 00859882007726

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Box 2
In Commercial Distribution

  • 00859882007726 ()


  • Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)
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