FDA.report

McKesson

Primary DI
00612479220768
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
170-71002
Device description
Foam Cushion HIGH DENSITY POLYURETHANE FOAM 18" x 16" x 3"
Published
2019-04-30
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
false

Related Records

Product Codes

CodeName
IMPCushion, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479220768PackageGS15In Commercial Distribution
00612479220751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479220768006124792207686124792207680612479220768
00612479220751006124792207516124792207510612479220751

GMDN Terms

TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
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
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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20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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