GenUltimate Zephyr!

GUDID 10860002137923

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: 10860002137923
• NIH Device Record Key: b3d92452-67d2-426b-b5fb-5c5ddcf69376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenUltimate Zephyr!
• Version Model Number: 104-50
• Company DUNS: 829145387
• Company Name: PHARMA TECH SOLUTIONS, INC.
• Device Count: 50
• 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	00860002137926 [Primary]
GS1	00860002137940 [Unit of Use]
GS1	10860002137916 [Package]; Package: [18 Units]; In Commercial Distribution
GS1	10860002137923 [Package]; Contains: 00860002137926; Package: [24 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: 2019-09-17
• Device Publish Date: 2019-09-09

On-Brand Devices [GenUltimate Zephyr!]

• 20860002137937: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr
• 10860002137923: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ultr