FDA.report

CARDINAL HEALTH

Primary DI
50885380170124
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB5068BY
Catalog number
CHB5068BY
Device description
Strap Tourniquet
Published
2019-10-11
Public version status
Update
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
50885380170124PackageGS14In Commercial Distribution
00885380170129PrimaryGS10
10885380170126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088538017012450885380170124
00885380170129008853801701298853801701290885380170129
1088538017012610885380170126

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
250
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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