FDA.report

NAR

Primary DI
00842209129164
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-4373
Catalog number
85-4373
Published
2023-11-16
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
00842209129164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209129164008422091291648422091291640842209129164

GMDN Terms

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

Regulatory Flags

DUNS number
832426782
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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00842209138258NAR77-014077-01402026-03-24
00842209138265NAR77-014177-01412026-03-24
00842209138272NAR77-014277-01422026-03-24

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