VeraSens Voice

GUDID 20857513006203

VeraSens Voice Blood Glucose Test Strip

i-SENS, Inc.

Glucose IVD, reagent

• Primary Device ID: 20857513006203
• NIH Device Record Key: 2a721fe0-f7c4-411a-ba88-ba365e1464ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeraSens Voice
• Version Model Number: 282104-201
• Company DUNS: 688840958
• Company Name: i-SENS, 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: false
• 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: 866-216-5308
• Email: jkupar@usdiagnostics.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857513006209 [Primary]
GS1	10857513006206 [Package]; Contains: 00857513006209; Package: Case Pack (Mid-Box) [50 Units]; In Commercial Distribution
GS1	20857513006203 [Package]; Contains: 10857513006206; Package: Master Case Carton [10 Units]; In Commercial Distribution
GS1	50857513006204 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121133

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [VeraSens Voice]

• 20857513006203: VeraSens Voice Blood Glucose Test Strip
• 10857513006190: VeraSens Voice Blood Glucose Meter