FDA.reportPublic FDA data

Bari+Max Bariatric Gel/Foam Cushion 26"x20"x3"

Primary DI
00840117321113
Brand
Bari+Max Bariatric Gel/Foam Cushion 26"x20"x3"
Company
Dynarex Corporation
Model
13052
Device description
Weight Capacity 500 lb.
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840117321144PackageGS15In Commercial Distribution
00840117321113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117321144008401173211448401173211440840117321144
00840117321113008401173211138401173211130840117321113

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.

Regulatory Flags#

DUNS number
008124539
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
true
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
00840117311411Resp-O2 Nasal O2 Cannula Cushion Tip331542021-04-22
00840117311435Resp-O2 Nasal O2 Cannula Cushion Tip331552021-04-22
00840117311459Resp-O2 Nasal O2 Cannula Cushion Tip331562021-04-22
00840117311473Resp-O2 Nasal O2 High Flow Cannula331602021-04-22
00840117311718Resp-O2 Nasal Oxygen Cannula Deluxe Ear Foam Covers333002021-04-22
00840117316416Resp-O2 Nasal O2 Cannula Cushion Tip331702021-04-22
00840117316423Resp-O2 Nasal O2 Cannula Cushion Tip331712021-04-22
00840117316430Resp-O2 Nasal O2 Cannula Cushion Tip331722021-04-22
00840117316447Resp-O2 Nasal O2 Cannula Cushion Tip331732021-04-22
00840117316454Resp-O2 Nasal O2 Cannula Cushion Tip331742021-04-22
00840117316461Nasal O2 Cannula Cushion Tip331752021-04-22
00840117316478Resp-O2 Nasal O2 Cannula Cushion Tip331762021-04-22
00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
00840117316584Resp-O2 EtCO2 Nasal Sampling Cannula331812021-04-22
00840117316591Resp-O2 EtCO2 Nasal Sampling Cannula331822021-04-22
00840117316607Resp-O2 EtCO2 Nasal Sampling Cannula331832021-04-22
00840117316614Resp-O2 EtCO2 Nasal Sampling Cannula331842021-04-22
00840117316621Resp-O2 EtCO2 Nasal Sampling Cannula331852021-04-22
00840117316638Resp-O2 EtCO2 Nasal Sampling Cannula331862021-04-22
00840117316645Resp-O2 EtCO2 Nasal Sampling Cannulas331872021-04-22

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