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 RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge 2 ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves 1 pr Alcohol Pads 2 ea Chlorhexidine Swab 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
08
Not in Commercial Distribution

  • M68980801R080 ()
80-801-R

  • Blood transfusion set, non-exchange
FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge 2 ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves 1 pr Alcohol Pads 2 ea Chlorhexidine Swab 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
07
In Commercial Distribution

  • M68980801R070 ()
80-801-R

  • Blood transfusion set, non-exchange
FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves (pair) 1 ea Alcohol Pads 2 ea Chlorhexidine Swap 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
06
Not in Commercial Distribution

  • M68980801R060 ()
80-801-R

  • Blood transfusion set, non-exchange
FRESH WHOLE BLOOD RECIPIENT SET Constricting Band (18"x1") 1 ea Gauze Sponge (4"x4") 2ea Safety IV Catheter 16gx1.25" 1 ea Safety IV Catheter 18gx1.25" 1 ea IV Set "Y" - Type with Filter 1 ea Surgical Tape 1 ea Clear IV Dressing 1 ea ABO/Rh Screen (EldonCard) 1 ea Gloves (pair) 1 ea Alcohol Pads 2 ea Chlorhexidine Swap 1 ea Permanent Marker 1 ea SF 518 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
03
Not in Commercial Distribution

  • M68980801R030 ()
80-801-R

  • Blood transfusion set, non-exchange
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Transfusion Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. The set includes a donor module, blood collection bag and recipient module; that allow for donor collection and the ability to perform a transfusion procedure to the recipient. Product Description 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 Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. RECIPIENT SET -PN: 80-801-R • Constricting Band (18”x1”) 1 ea • Gauze Sponge (4”x4”) 2 ea • Safety IV Catheter 16g x 1.25” 1 ea • Safety IV Catheter 18g x 1.25” 1 ea • IV Set “Y”-Type with filter 1 ea • Surgical Tape 1 ea • Clear IV Dressing 1 ea • ABO/Rh Screen (Eldon Card) 1 ea • Gloves (Pair) 1 ea • Alcohol Pads 2 ea • Chloraprep Swabstick 1 ea • Mini-Sharpie 1 ea • SF 518Form 1 ea • Instructions for Use 1 ea
Safeguard US Operating, LLC
1
Not in Commercial Distribution

  • M68980801R01 ()
80-801-R

  • Blood transfusion set, non-exchange
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 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 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 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 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
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