AccessGUDID - DEVICE: Champion (00850001188203)

GUDID

Device Identifier (DI) Information

Brand Name: Champion
Version or Model: 58P Series Medical Relax Recliner XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 58P Series XL
Company Name: Champion Manufacturing Inc.

Primary DI Number: 00850001188203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 786987859 *Terms of Use

Device Description: 58 Series, Medical Relax Recliner, XL Capacity, Power

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
34833	General-purpose stool/chair	A seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home.	Active	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: a0ed229f-a27c-4de6-80d9-2062fc422553
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023