GenUltimate

GUDID 00850015460036

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

PHARMA TECH SOLUTIONS, INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 00850015460036
• NIH Device Record Key: bbdf07e1-f766-4df0-8b0a-ffb0267848e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenUltimate
• Version Model Number: 300-25
• Company DUNS: 829145387
• Company Name: PHARMA TECH SOLUTIONS, INC.
• Device Count: 250
• 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: kberman@decisiondiagnostics.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015460036 [Primary]
GS1	00868906000131 [Unit of Use]
GS1	10850015460033 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	20850015460030 [Package]; Contains: 10850015460033; Package: [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103542

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

Devices Manufactured by PHARMA TECH SOLUTIONS, INC.

• 00850015460036 - GenUltimate: 2020-01-20Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 00850015460036 - GenUltimate: 2020-01-20 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 10860002137923 - GenUltimate Zephyr!: 2019-09-17 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 20860002137937 - GenUltimate Zephyr!: 2019-09-17 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 20860002137968 - Alltara Zephyr!: 2019-09-17 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 00860002137971 - Alltara Zephyr!: 2019-09-17 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 00867396000317 - Firefly: 2018-03-29 Single-Use Disposable Safety Lancets
• 00867396000324 - GenUltimate!: 2018-03-29 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
• 00868906000100 - GenUltimate!: 2018-03-29 Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters.