FDA.report

Medichoice

Primary DI
30885632070864
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
TRN1115
Device description
Tourniquet Perforated Roll Blue 1" x 18" Polyisoprene Blend Blue Economy
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
30885632070864PackageGS120In Commercial Distribution
20885632070867PrimaryGS10
10885632070860Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088563207086430885632070864
2088563207086720885632070867
1088563207086010885632070860

GMDN Terms

TermDefinition
Arm/leg tourniquet, single-useA non-sterile 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
007941230
Device count
25
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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