FDA.report

drive

Primary DI
00822383979540
Brand
drive
Company
Drive Devilbiss Healthcare
Model
PLTCABL
Device description
Beds LTC Accessories Product Description LTC Assist Bar, Left,1ea
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
00822383979540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383979540008223839795408223839795400822383979540

GMDN Terms

TermDefinition
Electrical assistive bedA mains electricity (AC-powered) bed designed for a person with a disability and operated by the occupant and/or an attendant using controls that activate electrically-powered motors that adjust the positioning of the mattress. It may have one or more sections of the mattress support platform that can be adjusted in height and/or angle.

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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