FDA.report

drive

Primary DI
00822383979441
Brand
drive
Company
Drive Devilbiss Healthcare
Model
P703WE
Device description
Beds LTC Accessories Product Description P703 Width Extension 39-42",1pr
Published
2020-07-01
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
00822383979441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383979441008223839794418223839794410822383979441

GMDN Terms

TermDefinition
Basic electric home bedA mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.

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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