FDA.reportPublic FDA data

MEDLINE

Primary DI
00080196404950
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSCCOMF2016
Catalog number
MSCCOMF2016
Device description
CUSHION,W/C,MEDLINE COMFORT,20X16
Published
2024-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00080196404950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00080196404950000801964049500801964049500080196404950

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07