FDA.reportPublic FDA data

NAR

Primary DI
00842209127108
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-4213
Published
2023-05-11
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

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
00842209127108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209127108008422091271088422091271080842209127108

GMDN Terms#

Term, Definition table
TermDefinition
Limb tourniquet, manual, single-useA strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10842942010894PRIMEDpriMED Medical Products IncGAX2026-03-03
10810132043410HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043427HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043434HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043441HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043458HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043465HCSConcordance Healthcare Solutions LLCGAX2025-12-05
00850063404396easycareSynchronis Medical, LLCGAX2025-12-05
00842209136636NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
00842209136643NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
07290012685477HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290012685491HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290020471000T.A.L Tactical Aid Lifesaver SINGER INSTRUMENTS & CONTROL LTD.GAX2025-09-25
00860003436424Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00860003436455Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00869193000040T-RING FLEX Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-11
10869193000016T-RING Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-10
08057592700025TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700032TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700049TOURNIK-ITFLAMOR SRLGAX2025-05-28
10661392011677LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392011691LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392053585LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
30665973032390DukalDukal LLCGAX2025-04-08
30665973032406DukalDukal LLCGAX2025-04-08
00840490800007PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800011PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800028PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800035PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
00840490800045PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04