FDA.reportPublic FDA data

Ever-Soft Alternating Pressure Air Cushion

Primary DI
00616784067513
Brand
Ever-Soft Alternating Pressure Air Cushion
Company
Dynarex Corporation
Model
10675
Published
2022-05-09
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
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784067544PackageGS15In Commercial Distribution
00616784067513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784067544006167840675446167840675440616784067544
00616784067513006167840675136167840675130616784067513

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure chair cushion, reusableA pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, 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. 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

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00840117337381LabChoice Pet Cell Bottle, 1000 mL431522025-06-16
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
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00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31

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