FDA.reportPublic FDA data

MEDLINE

Primary DI
20888277715919
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSCPRC22016CS
Catalog number
MSCPRC22016CS
Device description
CUSHION,W/C, GEL FOAM CUSHION,20X16X2,CS
Published
2024-08-06
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

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
20888277715919PackageGS14In Commercial Distribution
00888277715915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088827771591920888277715919
00888277715915008882777159158882777159150888277715915

GMDN Terms#

Term, Definition table
TermDefinition
Gel-filled chair cushionA gel-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H933EZ161896Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IMP2026-02-26
40080196312277MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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00860014212307Matrix AIREZ Custom BackMatrix Seating USA, LLCIMP2025-11-19
00860014212314Matrix AIREZ Custom CushionMatrix Seating USA, LLCIMP2025-11-19
00860014212321Matrix Custom Seat CushionMatrix Seating USA, LLCIMP2025-11-19
00860010877449Ease CushionEase Seating SystemsIMP2025-09-05
00860010877456Ease CushionEase Seating SystemsIMP2025-09-05
00860010877463Ease CushionEase Seating SystemsIMP2025-09-05
00860010877470Ease CushionEase Seating SystemsIMP2025-09-05
00840117321915DMECare Solutions Ever-Soft Lumbar Support Cushion,18"Dynarex CorporationIMP2025-08-22
00840117321939DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" Dynarex CorporationIMP2025-08-22
00840117321953DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"Dynarex CorporationIMP2025-08-22
09420082600096Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600133Spex LimitedSPEX LIMITEDIMP2025-05-31
09420082600065Spex LimitedSPEX LIMITEDIMP2025-05-30
09420082600072Spex LimitedSPEX LIMITEDIMP2025-05-30