In Touch Glucose Control Solutions OFG00140

GUDID 00853553005028

Box of High/Low Control Solution

LIVONGO HEALTH, INC

Glucose IVD, control

• Primary Device ID: 00853553005028
• NIH Device Record Key: c73d5f38-e850-4883-8e51-17458131191a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In Touch Glucose Control Solutions
• Version Model Number: In Touch
• Catalog Number: OFG00140
• Company DUNS: 829984561
• Company Name: LIVONGO HEALTH, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: 800.945.4355
• Email: membersupport@livongo.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2016-09-24

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