FDA.reportPublic FDA data

Whole Blood Collection and Transfusion Kit

Primary DI
00856767008083
Brand
Whole Blood Collection and Transfusion Kit
Company
Chinook Medical Gear
Model
3425
Published
2018-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
POQBlood Transfusion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856767008083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856767008083008567670080838567670080830856767008083

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion setA sterile, intravascular administration set 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

Regulatory Flags#

DUNS number
621904622
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018892865Chinook Chest Drain Valve99671996712020-12-14
00850018892902Vaccine Administration Kit, Individual04654046542020-12-14
00850018892919Vaccine Administration Kit, Facility04656046562020-12-14
00850018892896IV Start Kit w/Catheter, 18Ga0202100202102020-12-08
00850018892858My PAK, (Personal Aid Kit), Child, Black02803BK02803BK2020-08-11
00856767008366My PAK, Child02803RD02803RD2020-05-19
00850018201780TMK-UTQ Pouch, OD601324OD601324OD2020-05-22
00850018892841TravelerPAK01484014842020-06-24
00850018892506IFAK Insert Kit, Black01237BK01237BK2020-05-29
00850018892513IFAK Insert Kit, Coyote Brown01237CB01237CB2020-05-29
00850018892520IFAK Insert Kit, Refill, Contents Only01237REF01237REF2020-05-29
00850013417094Cravat/Triangular Bandage, Box 5005001-5005001-502020-05-18
00850013417100Cravat/Triangular Bandage, Each05001050012020-05-18
00850013417568Bleeding & CPR Basic Kit (EPMK)01428RD01428RD2020-05-18
00850013417599Individual Operator Kit, (LEMK-IO), Black w/CAT02172BK-CAT02172BK-CAT2020-05-18
00850013417605Individual Operator Kit, (LEMK-IO), Black w/SOFTT-W02172BK02172BK2020-05-18
00850013417612Individual Operator Kit, (LEMK-IO), Olive Drab w/SOFTT-W02172OD02172OD2020-05-18
00850013417629Individual Operator Kit, (LEMK-IO), Olive Drab w/CAT02172OD-CAT02172OD-CAT2020-05-18
00850013417636Individual Operator Kit, (LEMK-IO), Refill w/CAT, Contents Only02172REF-CAT02172REF-CAT2020-05-18
00850013417643Individual Operator Kit, (LEMK-IO), Refill w/SOFTT-W, Contents Only02172REF02172REF2020-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980820120Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2026-01-22
M68980821110Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2026-01-22
M68980801060Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2025-05-05
M68980821100Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2024-12-27
M68980820110Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2024-12-16
00856767008045Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low TiterAltitude Technologies Inc.POQ2024-01-18
00842209128129NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00842209128198NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00810094575878CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575885CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
M68980820070Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-11-04
M68980821070Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-11-04
M68980801040Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-10-05
00842209124619NAR KitNORTH AMERICAN RESCUE, LLCPOQ2022-08-31
M68980820060Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-08-22
M68980821060Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-08-22
M68980801050Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-08-09
M68980821050Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-10-02
M68980820050Valkyrie LTOWB Collection SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2021-10-02
M68980801030Fresh Whole Blood Transfusion SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2021-10-01
00850015884009ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
00850015884061ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
M68980820040Valkyrie LTOWB Collection SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2021-07-19
M68980821040Valkyrie LTOWB Administration SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2021-07-19
00812277037142CuraplexBOUND TREE MEDICAL, LLCPOQ2021-02-28
00842209118182NAR KitNORTH AMERICAN RESCUE, LLCPOQ2021-02-08
M68980820020Valkyrie LTOWB Collection SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2020-12-15
M68980821020Valkyrie LTOWB Administration SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2020-12-15
00850015884108ForwardSYNCHRONIS MEDICAL, LLCPOQ2020-08-13
00856767008151TMM-LTA (Tactical Medical Module-Low Titer Administration)Altitude Technologies Inc.POQ2020-05-21