GenUltimate!

Basic Information

• Brand Name: GenUltimate!
• Primary DI: 00868906000100
• Version / Model: 100-50
• Catalog Number: 100-50
• Company Name: PHARMA TECH SOLUTIONS, INC.
• Labeler DUNS: 829145387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9368f0cd-a038-444b-9305-a96944a294d6

Device Description

Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47654	Home-use/point-of-care glucose rapid test/blood pressure system analyser	A portable, battery-powered instrument used with other devices (e.g., reagents, test strips, a blood pressure cuff, and accessories) to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. The measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868906000100	GS1
Package	10868906000121	GS1	Case	18	In Commercial Distribution
Package	10868906000107	GS1	Inner Pack	24	In Commercial Distribution
Unit of Use	00868906000131	GS1

Customer Contacts

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