FDA.report

Drive

Primary DI
00822383530819
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
AM-ATC19-BL
Device description
Transport/WheelchairTransport Chairs Product Description: Amer,Transport Chair,Alum.19" Blue,1/ea
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
INNCHAIR, ADJUSTABLE, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383530819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383530819008223835308198223835308190822383530819

GMDN Terms

TermDefinition
Transport wheelchair, collapsibleA wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.

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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