FDA.report

DRIVE

Primary DI
00822383255293
Brand
DRIVE
Company
Drive Devilbiss Healthcare
Model
0-99545
Device description
Pressure Prevention Retail Foam Product Description Bed Wedge 23x23x12, 1ea, 4/cv
Published
2020-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OSIBariatric bed

Product Code Classifications

CodeDeviceSpecialtyClass
OSIBariatric BedGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383255293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383255293008223832552938223832552930822383255293

GMDN Terms

TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

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
true
Sterilization required before use
false

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