FDA.report

MediChoice

Primary DI
20885632063296
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GEY2APD
Device description
Wheelchair Replacement Desk Style Armpad Only Includes Armpad Fits All MediChoice Standard Heavy-Duty Lightweight And Reclining Wheelchairs Vinyl Black Not Nat Rubber Ltx Non Sterile Reusable MediChoice
Published
2020-10-13
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
IMLARMREST, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
IMLArmrest, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885632063296PackageGS110In Commercial Distribution
10885632063299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088563206329620885632063296
1088563206329910885632063299

GMDN Terms

TermDefinition
Wheelchair armrestA small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Protect from water damage, Protect from sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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