AccessGUDID - DEVICE: Pharmaceutical Innovations (00300361100013)

GUDID

Device Identifier (DI) Information

Brand Name: Pharmaceutical Innovations
Version or Model: UltraWarmer Gel Warmer - White
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36-1100-01
Company Name: PHARMACEUTICAL INNOVATIONS INC

Primary DI Number: 00300361100013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067486548 *Terms of Use

Device Description: UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. White.

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?
17506	Gel warmer	A portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFC	Warmer, Anesthetic Tube

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: e6735cfe-6f5b-4f2e-8708-94875df51d58
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016