FDA.reportPublic FDA data

NAR

Primary DI
00842209128198
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
83-0035
Catalog number
83-0035
Device description
KIT, FBTK DONOR MODULE w/o BLOOD BAG
Published
2023-08-10
Public version status
New
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
00842209128198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209128198008422091281988422091281980842209128198

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
00842209139620NAR84-0004A84-0004A2026-08-19
00842209139637NAR84-0007A84-0007A2026-08-19
00842209139644NAR84-0020A84-0020A2026-08-19
00842209139651NAR84-0023A84-0023A2026-08-19
00842209139668NAR84-0135A84-0135A2026-08-19
00842209139675NAR84-0138A84-0138A2026-08-19
00842209139682NAR80-1483A80-1483A2026-08-19
00842209139699NAR80-198580-19852026-08-19
00842209139705NAR84-020584-02052026-08-19
00842209139712NAR77-015377-01532026-08-19
00842209139729NAR82-0049P82-0049P2026-08-19
00842209139736NAR82-0051P82-0051P2026-08-19
00842209139743NAR82-0075P82-0075P2026-08-19
00842209139750NAR82-0077P82-0077P2026-08-19
00842209139767NAR80-1166P80-1166P2026-08-19
00842209139774NAR80-1593P80-1593P2026-08-19
00842209139781NAR80-1612P80-1612P2026-08-19
00842209139798NAR80-186980-18692026-08-19
00842209139804NAR80-189180-18912026-08-19
00842209139811NAR85-519685-51962026-08-19

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
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
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
00850015884061ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
M68980820040Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-07-19
M68980821040Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-07-19
00812277037142CuraplexBOUND TREE MEDICAL, LLCPOQ2021-02-28
00842209118182NARNORTH AMERICAN RESCUE, LLCPOQ2021-02-08