FDA.report

NAR

Primary DI
00842209128129
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
83-0036
Catalog number
83-0036
Device description
KIT, FIELD BLOOD TRANSFUSION 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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
POQBlood Transfusion Kit

Product Code Classifications

CodeDeviceSpecialtyClass
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842209128129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209128129008422091281298422091281290842209128129

GMDN Terms

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

Regulatory Flags

DUNS number
832426782
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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00842209138081NAR84-019184-01912026-03-24
00842209138098NAR84-019484-01942026-03-24
00842209138104NAR84-019584-01952026-03-24
00842209138111NAR80-196280-19622026-03-24
00842209138128NAR85-506985-50692026-03-24
00842209138135NAR85-508785-50872026-03-24
00842209138142NAR80-189980-18992026-03-24
00842209138159NAR80-190980-19092026-03-24
00842209138166NAR85-507585-50752026-03-24
00842209138173NAR85-508585-50852026-03-24
00842209138180NAR85-509285-50922026-03-24
00842209138197NAR85-509485-50942026-03-24
00842209138203NAR85-509585-50952026-03-24
00842209138210NAR80-197280-19722026-03-24
00842209138227NAR80-197380-19732026-03-24
00842209138234NAR77-013877-01382026-03-24
00842209138241NAR77-013977-01392026-03-24
00842209138258NAR77-014077-01402026-03-24
00842209138265NAR77-014177-01412026-03-24
00842209138272NAR77-014277-01422026-03-24

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00842209128198NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
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M68980801040Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-10-05
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M68980820060Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-08-22
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M68980801050Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-08-09
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M68980801030Fresh Whole Blood Transfusion SetCOMBAT MEDICAL SYSTEMS, LLCPOQ2021-10-01
00850015884009ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
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00812277037142CuraplexBOUND TREE MEDICAL, LLCPOQ2021-02-28
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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
00856767008243TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)Altitude Technologies Inc.POQ2020-05-21