FDA.reportPublic FDA data

NAR

Primary DI
00842209103720
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
83-0001
Catalog number
83-0001
Device description
KIT, FBTK DONOR MODULE
Published
2018-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00842209103720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209103720008422091037208422091037200842209103720

GMDN Terms#

Term, Definition table
TermDefinition
Blood donor set, single-packAn assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209140367NAR85-523385-52332026-10-14
00842209140374NAR85-523485-52342026-10-14
00842209140381NAR85-524085-52402026-10-14
00842209140398NAR Kit88-005088-00502026-10-14
00842209140404NAR80-0097-TLS80-0097-TLS2026-10-14
00842209140411NAR80-198980-19892026-10-14
00842209140428NAR80-201580-20152026-10-14
00842209140435NAR85-392785-39272026-10-14
00842209140442NAR85-523685-52362026-10-14
00842209140459NAR85-524185-52412026-10-14
00842209140466NAR85-524585-52452026-10-14
00842209140473NAR80-0494A80-0494A2026-10-14
00842209140480NAR80-1091A80-1091A2026-10-14
00842209140497NAR80-0951A80-0951A2026-10-14
00842209140503NAR80-1166A80-1166A2026-10-14
00842209140510NAR80-1157A80-1157A2026-10-14
00842209140527NAR82-0058A82-0058A2026-10-14
00842209140534NAR82-0076A82-0076A2026-10-14
00842209140541NAR82-0051A82-0051A2026-10-14
00842209140558NAR82-0055A82-0055A2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209140244NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140251NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140268NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00850062467217Fresh Whole Blood Transfusion KitAltitude Technologies Inc.POQ2026-08-27
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
00850062467019Project Lavoy Blood KitAltitude Technologies Inc.POQ2024-06-19
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
00810094575823CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575830CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
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
00842209124619NARNORTH 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 SetSafeguard US Operating, LLCPOQ2021-10-02
M68980801030Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2021-10-01
00860000925310ForwardSynchronis Medical, LLCPOQ2021-09-17
00860000925372ForwardSynchronis Medical, LLCPOQ2021-09-17
00850015884009ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17