FDA.report

NAR

Primary DI
00842209130269
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-1819
Catalog number
85-1819
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications

CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842209130269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209130269008422091302698422091302690842209130269

GMDN Terms

TermDefinition
Emergency tourniquet, manual, single-useA device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening bleeding (e.g., in a military setting and/or high-risk work environment); it may additionally be used in non-life-threatening injuries. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
832426782
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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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