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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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ABSORBENT POINTS (100/box) Type: .04 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/30500/s/tapered-asorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9194
In Commercial Distribution

  • D77810391940 ()
  • D77810391941 ()
103-9194

  • Endodontic paper point
GUTTA PERCHA POINTS (100/box) Type: .04 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9152
In Commercial Distribution

  • D77810391520 ()
  • D77810391521 ()
103-9152

  • Natural gutta-percha
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
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 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
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
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