Fresh Whole Blood Recipient Set

Primary DI
M68980801R020
Brand
Fresh Whole Blood Recipient Set
Company
Safeguard US Operating, LLC
Model
2
Catalog number
80-801-R
Device description
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 DescriptionIn 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.
Published
2017-08-04
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#

Product Codes#

Code, Name table
CodeName
BRZSet, Blood Transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRZSet, Blood TransfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68980801R020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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