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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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ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740193720

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6001
In Commercial Distribution

  • 00380740193720 ()
06S6001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740175481

ARCHITECT STAT High Sensitivity Troponin-I Controls
ABBOTT IRELAND
02R9810
In Commercial Distribution

  • 00380740175481 ()
02R9810

  • Troponin I IVD, control

Alinity - 00380740165482

Alinity i STAT CK-MB Calibrators
Abbott Ireland Diagnostics
04V3801
In Commercial Distribution

  • 00380740165482 ()
04V3801

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Fresh Whole Blood Donor Transfusion Set - M68980801D150

The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
15
In Commercial Distribution

  • M68980801D150 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D140

The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
14
In Commercial Distribution

  • M68980801D140 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D110

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution

  • M68980801D110 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D090

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
09
In Commercial Distribution

  • M68980801D090 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D080

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
8
Not in Commercial Distribution

  • M68980801D080 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D070

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
7
Not in Commercial Distribution

  • M68980801D070 ()
80-801-D

  • Blood donor set, single-pack
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