CareLiving MM1100 Blood Glucose Test Strips 50ct 83568-1007-41

GUDID 10383568100748

Blood Glucose Test Strips,2 bottles of 25 strips in one 50 strip box, for use with blood glucose monitoring system

Care Living Diagnostics Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10383568100748
• NIH Device Record Key: 64d758b7-7184-4f77-b231-41bcfea45890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLiving MM1100 Blood Glucose Test Strips 50ct
• Version Model Number: MM1100-50ct
• Catalog Number: 83568-1007-41
• Company DUNS: 125354643
• Company Name: Care Living Diagnostics 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: true
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com
• Phone: 1-888-811-9866
• Email: service@careliving.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383568100741 [Primary]
GS1	10383568100748 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111456

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: 2024-04-29
• Device Publish Date: 2024-04-19

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