FDA.reportPublic FDA data

NAR

Primary DI
00842209116157
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-0924
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209116157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209116157008422091161578422091161570842209116157

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209140169NAR80-0419-TLS80-0419-TLS2026-09-28
00842209140176NAR80-199080-19902026-09-28
00842209140183NAR85-515785-51572026-09-28
00842209140190NAR85-516685-51662026-09-28
00842209140206NAR85-516785-51672026-09-28
00842209140213NAR10-0052-TLS10-0052-TLS2026-09-28
00842209140220NAR30-0013-TLS30-0013-TLS2026-09-28
00842209140237NAR80-201380-20132026-09-28
00842209140244NAR83-0000-TLS83-0000-TLS2026-09-28
00842209140251NAR83-0001-TLS83-0001-TLS2026-09-28
00842209140268NAR83-0002-TLS83-0002-TLS2026-09-28
00842209140275NAR83-0007-TLS83-0007-TLS2026-09-28
00842209140282NAR85-500785-50072026-09-28
00842209140299NAR80-189580-18952026-09-28
00842209140305NAR80-198680-19862026-09-28
00842209140312NAR85-512785-51272026-09-28
00842209140329NAR85-522585-52252026-09-28
00842209140336NAR85-523585-52352026-09-28
00842209140343NAR85-523085-52302026-09-28
00842209128198NAR83-003583-00352023-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061187185EVERLITEverlit Global Inc.GAX2026-09-28
00850061187192EVERLITEverlit Global Inc.GAX2026-09-28
00850061187208EVERLITEverlit Global Inc.GAX2026-09-28
00850061187215EVERLITEverlit Global Inc.GAX2026-09-28
00199536932005BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932012BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932029BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932036BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932043BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932050BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
00199536932067BluelineTransparent Supply Solutions Ltd.GAX2026-08-14
40884389110493MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-07-03
40888277362261MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-06-09
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
00842942010897PRIMEDpriMED Medical Products IncGAX2026-03-03
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
05060483571867TMT (Tactical Mechanical Tourniquet)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDGAX2024-10-02
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
00630094049182Bioseal Inc.BIOSEALGAX2024-01-25
00630094049199Bioseal Inc.BIOSEALGAX2024-01-25