Pharmaceutical Innovations

Basic Information

• Brand Name: Pharmaceutical Innovations
• Primary DI: 00300361100020
• Version / Model: UltraWarmer Gel Warmer - Navy
• Catalog Number: 36-1100-02
• Company Name: PHARMACEUTICAL INNOVATIONS INC
• Labeler DUNS: 067486548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 080a13aa-8b91-41d4-9964-cc7d9ff4504d

Device Description

UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Navy.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFC	Warmer, Anesthetic Tube	Dental	872.6100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10300361100027	GS1		1	In Commercial Distribution
Primary	00300361100020	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]