AccessGUDID - DEVICE: MediChoice (10885632108280)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: BTH310
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632108280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Shower Chair Transport Aluminum Frame Removable Nylon Backrest Overall 21.5 Wide X 24 Deep X 39 High Seat Area 14 Wide X 16.5 Deep X 22 High 5 Inch Locking Casters 250-pound Evenly Distributed Weight Capacity Not Made With Natural Rubber Latex MediChoice

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45353	Transport wheelchair, non-collapsible	A 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 cannot be folded or readily dismantled for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
INN	CHAIR, ADJUSTABLE, MECHANICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6062753c-9c99-4370-a8f2-5ae3c48ed332
Public Version Date: October 28, 2020
Public Version Number: 1
DI Record Publish Date: October 20, 2020