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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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Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
4R4750
In Commercial Distribution

  • 00812269031295 ()
  • 10812269031285 ()
  • 00812269031288 ()


  • Blood donor bag segment sampling IVD
Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
TS500
In Commercial Distribution

  • 20812269031275 ()
  • 10812269031278 ()
  • 00812269031271 ()


  • Blood donor bag segment sampling IVD
Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD
Typesafe 2.0 - Quantity 500
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution

  • 00812269031240 ()
  • 10812269031230 ()
  • 00812269031233 ()


  • Blood donor bag segment sampling IVD
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 10852714003108 ()


  • Wound dressing kit, medicated
Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives.
IMMUCOR, INC.
0066906
In Commercial Distribution

  • 10888234002314 ()
0066906

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.
IMMUCOR, INC.
0066908
In Commercial Distribution

  • 10888234002291 ()
0066908

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the single 57 mL bottle version.
IMMUCOR, INC.
0006418
In Commercial Distribution

  • 10888234002147 ()
0006418

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
IMMUCOR, INC.
0066905
In Commercial Distribution

  • 10888234001577 ()
0066905

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
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