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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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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

Fresh Whole Blood Donor Transfusion Set - M68980801D040

FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea Blood Tube- Lavender Top 4 ea Chlorhexidine Swab 1 ea Blood Tube- Red Top 2 ea 5.5” Kelly Clamp 1 ea Blood Collection Needle 21gx1.25" 1 ea Nylon Cord (10”) 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
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801D040 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D020

Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68980801D020 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Donor Transfusion Set - M68980801D0

Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea
Safeguard US Operating, LLC
1
Not in Commercial Distribution

  • M68980801D0 ()
80-801-D

  • Blood donor set, single-pack

Fresh Whole Blood Transfusion Set - M68980801060

The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
Safeguard US Operating, LLC
06
In Commercial Distribution

  • M68980801060 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack

Fresh Whole Blood Transfusion Set - M68980801050

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack

Fresh Whole Blood Transfusion Set - M68980801040

FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801040 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
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