AccessGUDID - DEVICE: Aquatec Ocean -Dual VIP Kit Series (04028698104486)

GUDID

Device Identifier (DI) Information

Brand Name: Aquatec Ocean -Dual VIP Kit Series
Version or Model: 1470829
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1470829
Company Name: INVACARE CORPORATION

Primary DI Number: 04028698104486
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: Basic US Model Ocean Dual-VIP Kit

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?
31057	Basic toilet seat	A seat intended to be attached to a toilet bowl or toilet chair to provide conventional position, stability, and/or comfort to a seated occupant while toileting.	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: 13758451-169f-4aef-9e09-15df909cbdd4
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: March 12, 2019