Fresh Whole Blood Transfusion Set - Designed for missions in the most remote and - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: Designed for missions in the most remote and austere environments, the Fresh Whole Blood T 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.Combat Capabilities• Easily administered• Simplifies training• Compact lightweight• Cost effectiveProduct Attributes• 100% TAA compliant components (no waivers required)• Donor and recipient specific modules• Shelf life: 12 months• Made in USAClinical Benefit• Assembled in FDA registered 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.

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More Product Details

Catalog Number

80-801

Brand Name

Fresh Whole Blood Transfusion Set

Version/Model Number

2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

POQ

Product Code Name

Blood Transfusion Kit

Device Record Status

Public Device Record Key

640b1359-dfff-4eb5-bdf2-32a8b4ba8fe3

Public Version Date

April 12, 2022

Public Version Number

5

DI Record Publish Date

August 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48