AccessGUDID - DEVICE: Aquasence (00754021216178)

GUDID

Device Identifier (DI) Information

Brand Name: Aquasence
Version or Model: 770-602
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00754021216178
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Bath SafetyRaised Toilet Seat Product Description: AQS TOILET ST 4"RISER Elon. 1EA,4CV,Re

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):	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?
31059	Raised toilet seat	A non-powered seat of fixed height designed to enable a person with a disability to sit on the toilet at an elevation above the conventional range for easier sitting and standing. It may be intended to attach to a standard toilet bowl or may be freestanding; it might also include armrests/bars to assist transfer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILS	ADAPTOR, HYGIENE

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: 8c31358a-d987-45d6-8b65-8ec193e423e0
Public Version Date: October 21, 2024
Public Version Number: 3
DI Record Publish Date: June 21, 2019