COOL

GUDID 20885325000379

COOL Blood Glucose Monitoring System

i-SENS, Inc.

Home-use/point-of-care blood glucose monitoring system IVD

• Primary Device ID: 20885325000379
• NIH Device Record Key: cf45fa08-6b29-43e8-8c94-54e3652b021b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOL
• Version Model Number: 521100
• Company DUNS: 688840958
• Company Name: i-SENS, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: 855-646-3231
• Email: xxx@xxx.xxx
• Phone: 855-646-3231
• Email: xxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885325000375 [Primary]
GS1	10885325000372 [Package]; Contains: 00885325000375; Package: Case Pack (Mid-Box) [4 Units]; In Commercial Distribution
GS1	20885325000379 [Package]; Contains: 10885325000372; Package: Master Case Carton( [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103396

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 [COOL]

• 20885325000812: COOL Blood Glucose Test Strip
• 20885325000768: COOL Blood Glucose Test Strip
• 20885325000751: COOL Blood Glucose Meter
• 20885325000379: COOL Blood Glucose Monitoring System