AccessGUDID - DEVICE: HR Ultrasound Jelly (00851809002142)

GUDID

Device Identifier (DI) Information

Brand Name: HR Ultrasound Jelly
Version or Model: 214
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 214
Company Name: HR PHARMACEUTICALS INC.

Primary DI Number: 00851809002142
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 828918164 *Terms of Use

Device Description: Sterile Ultrasound Gel Flip Top Tube

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?
15321	Skin topical coupling gel	A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Fluid Ounce

Device Record Status

Public Device Record Key: 93fa9fbb-248a-4731-9234-42450aaff17a
Public Version Date: September 21, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016