AccessGUDID - DEVICE: AQUASONIC 100 (30855683006044)

GUDID

Device Identifier (DI) Information

Brand Name: AQUASONIC 100
Version or Model: ULTRASOUND TRANSMISSION GEL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-08-700189/40483A
Company Name: PARKER LABORATORIES INC

Primary DI Number: 30855683006044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 002449593 *Terms of Use

Device Description: AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 0.25L

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):	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?
11425	Electrode conductive medium	A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media,Coupling,Ultrasound

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: b478a975-899c-45e7-b5de-c106bd1c017a
Public Version Date: October 22, 2018
Public Version Number: 3
DI Record Publish Date: July 05, 2017