FDA.reportPublic FDA data

Low Titer Type O FWB Transfusion Set

Primary DI
M68980875100
Brand
Low Titer Type O FWB Transfusion Set
Company
Safeguard US Operating, LLC
Model
10
Catalog number
80-875
Device description
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.Pre-screening to identify Type O Low Titer Donors in the operational forces is the next evolution in forward fresh whole blood resuscitation. This advancement simplifies this task by reducing the steps, supplies and time required to perform this lifesaving intervention.This self contained, low cube set is an affordable and sensible solution for training and equipping organizations that pre-identify their donors.
Published
2025-02-09
Public version status
New
Distribution status
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
M68980875100PrimaryHIBCC0

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.

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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M6898810503070Patrol Officer IFAK Advanced0788-105-032026-07-27
M6898723101020Bleeding Control Kit0287-231-012026-07-22
M68920510060Sentinel Chest Trauma Kit0620-5102022-11-28
M68920510050Sentinel Chest Trauma Kit0520-5102022-08-18
M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801R120Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2026-05-04
M68980801R110Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2025-03-04
M68980801R100Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2024-12-16
M68980875090Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-11-04
M68980801R080Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-30
M68980801R070Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2022-09-27
M68980875080Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2022-08-23
00085412653303EXTENSION SETBAXTER HEALTHCARE CORPORATIONBRZ2021-12-23
50085412653308EXTENSION SETBAXTER HEALTHCARE CORPORATIONBRZ2021-12-23
M68980801R060Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2021-10-02
M68980875070Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2021-07-28
M68980875030Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2020-03-12
M68980875D030Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2020-03-12
03660812118484VYGONVYGONBRZ2020-01-29
53660812118489VYGONVYGONBRZ2020-01-29
03660812106122VYGONVYGONBRZ2019-06-26
53660812106127VYGONVYGONBRZ2019-06-26
M69880875020Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875D020Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-09-18
M68980875010Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2018-05-04
M68980875D010Low Titer Type O Donor Collection SetSafeguard US Operating, LLCBRZ2018-05-04
M68980801R030Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2018-05-04
04052682004148Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer AdapterFresenius Kabi AGBRZ2018-03-26
04052682004193Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer AdapterFresenius Kabi AGBRZ2018-03-26
14052682004145Fenwal Blood Comp. Recipient Set with Std. Blood FFresenius Kabi AGBRZ2018-03-26
14052682004190Fenwal Y-Type Blood Comp. Recipient Set with Std. Fresenius Kabi AGBRZ2018-03-26
M68980801R020Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-08-04
M68980801R01Fresh Whole Blood Recipient SetSafeguard US Operating, LLCBRZ2017-01-23
00085412002408INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24
00085412004006INTERLINKBAXTER INTERNATIONAL INC.BRZ2016-09-24