AccessGUDID - DEVICE: Aquasence (00754021210527)

GUDID

Device Identifier (DI) Information

Brand Name: Aquasence
Version or Model: 785-136
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00754021210527
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 SafetyGrab Bars Product Description: AqS GRAB BAR 24" ROTATE, 1EA, 12CV, 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?
35584	Bath hand rail	A bar intended to provide a supportive hand-hold for a person with a disability when raising or lowering themselves or changing their body position while bathing in a bath or bathing facility. It will typically be affixed to or around the bath.	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: 64882b9d-9dcc-4cca-b16f-d145102675df
Public Version Date: June 02, 2020
Public Version Number: 2
DI Record Publish Date: June 21, 2019