AccessGUDID - DEVICE: Invacare I-Class All-In-One Commode

GUDID

Device Identifier (DI) Information

Brand Name: Invacare I-Class All-In-One Commode - Single Pack
Version or Model: 9630-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9630-1
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447102403
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: Invacare I-Class All-In-One Commode - Single Pack

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:	No
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?
34934	Patient lifting system bath chair	A lifting device designed with a seat, and typically with legs and a back support, used with a patient lifting system to seat, lift, and transfer an incapacitated, geriatric, or disabled patient from a wheelchair into a bath or a tub (prefilled with bathing water or not) and back out again after the bathing session has been completed.	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: 17536d93-c924-42b3-aaf1-84124347f980
Public Version Date: October 02, 2023
Public Version Number: 2
DI Record Publish Date: June 10, 2019