FDA.report

DRIVEMEDICAL

Primary DI
50822383110764
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
14003-EF
Device description
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad, w/End Flaps,1/ea, RTL
Published
2019-06-21
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
false

Related Records

Product Codes

CodeName
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383110764PackageGS110In Commercial Distribution
00822383110769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238311076450822383110764
00822383110769008223831107698223831107690822383110769

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay, reusableA pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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