Fresh Whole Blood Donor Transfusion Set

Primary DI
M68980801D0
Brand
Fresh Whole Blood Donor Transfusion Set
Company
Safeguard US Operating, LLC
Model
1
Catalog number
80-801-D
Device description
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 effectiveProduct 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
Published
2017-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68980801D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, single-packAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 20 to 25 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedicalsystems.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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