GenUltimate! 100-10

GUDID 00867396000324

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

PHARMA TECH SOLUTIONS, INC.

Home-use/point-of-care glucose rapid test/blood pressure system analyser

• Primary Device ID: 00867396000324
• NIH Device Record Key: 2667a4ea-2ba7-4cbb-8322-266b3e065492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenUltimate!
• Version Model Number: Catalog Number: 100-10
• Catalog Number: 100-10
• Company DUNS: 829145387
• Company Name: PHARMA TECH SOLUTIONS, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 805-446-2973
• Email: intermania@aol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867396000324 [Primary]
GS1	00868906000131 [Unit of Use]
GS1	10867396000321 [Package]; Package: Case [432 Units]; In Commercial Distribution
GS1	20867396000328 [Package]; Package: Inner Pack [24 Units]; In Commercial Distribution

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-24

On-Brand Devices [GenUltimate!]

• 00868906000100: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr
• 00867396000324: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr