CareSens N

GUDID 10885325000013

CareSens N Blood Glucose Monitoring System

i-SENS, Inc.

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

• Primary Device ID: 10885325000013
• NIH Device Record Key: cfdedc7f-1ff6-45c1-875b-4b9bc12330e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSens N
• Version Model Number: 164303-201
• 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: 1-800-429-5001
• Email: cs1@i-sens.com
• Phone: 1-800-429-5001
• Email: cs1@i-sens.com

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	00885325000016 [Primary]
GS1	10885325000013 [Package]; Contains: 00885325000016; Package: Master Case Carton [70 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083468

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 [CareSens N]

• 10885325000112: CareSens N Blood Glucose Meter
• 20885325000027: CareSens N Blood Glucose Test Strip
• 10885325000013: CareSens N Blood Glucose Monitoring System