FDA.report

DRIVEMEDICAL

Primary DI
00057565991007
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
700-841
Device description
Transport/WheelchairTransport Chairs Product Description: Airgo 17" TC, Black, 1 EA,2CV,Ret.
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
INMCHAIR, WITH CASTERS

Product Code Classifications

CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00057565991007PackageGS12In Commercial Distribution
00057565982210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00057565991007000575659910070575659910070057565991007
00057565982210000575659822100575659822100057565982210

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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