FDA.reportPublic FDA data

Low Titer Type O Donor Collection Set

Primary DI
M68980875D010
Brand
Low Titer Type O Donor Collection Set
Company
Safeguard US Operating, LLC
Model
01
Catalog number
80-875-D
Device description
"LOW TITER TYPE O DONOR COLLECTION SETConstricting Band (18""x1"") 1 eaSafety IV Catheter 16gx1.25"" 2 eaTransparent Film Dressing 2 eaChlorhexidine Swap 4 eaBlood Collection Bag 1 eaBeaded Cable Tie 1eaNeedle-Free Valve with Luer Lock 2 eaDD Form 572 1 ea"
Published
2018-05-04
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
M68980875D010PrimaryHIBCC0

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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M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
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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
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20
M6898810503020Patrol Officer IFAK Advanced0288-105-032018-09-20
M6898810502030Patrol Officer IFAK Intermediate0388-105-022020-01-06
M6898810503030Patrol Officer IFAK Advanced0388-105-032020-01-06
M689PBEFAK010Point Blank Enterprises Employee FAK - Private Label01PBEFAK2026-07-09
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KIT03SH-START-PAX-SM2026-06-22
M689SHSTARTSM030School Trauma Active Response Kit03SH-START-SM2026-06-22

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
M68980875100Low Titer Type O FWB Transfusion SetSafeguard US Operating, LLCBRZ2025-02-09
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
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