FDA.reportPublic FDA data

DMI

Primary DI
00041298080077
Brand
DMI
Company
D-M-S HOLDINGS, INC.
Model
513-8006-0023
Device description
Ring Inflatable Rubber Large
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041298080074PackageGS124In Commercial Distribution
00041298080077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004129808007410041298080074
00041298080077000412980800770412980800770041298080077

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled chair cushionA static-air-inflated 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.

Regulatory Flags#

DUNS number
062028220
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113445ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113452ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113469ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113476ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113483ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113490ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113506ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113513ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113520ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00089904011497Action®ACTION PRODUCTS, INC.KIC2026-09-22