DEVICE: Fresh Whole Blood Donor Transfusion Set (M68980801D020)
Device Identifier (DI) Information
Fresh Whole Blood Donor Transfusion Set
2
Not in Commercial Distribution
80-801-D
Safeguard US Operating, LLC
2
Not in Commercial Distribution
80-801-D
Safeguard US Operating, LLC
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44033 | Blood donor set, single-pack |
An assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.
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FDA Product Code
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at 20 to 25 degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bb04ea96-595a-4cd1-8b31-0bdfcc151b80
April 12, 2022
5
August 04, 2017
April 12, 2022
5
August 04, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
855-428-6074
fulfillment@combatmedicalsystems.com
fulfillment@combatmedicalsystems.com