In Touch Lancing Device OFG00156

GUDID 00853553005141

Box of 1 Lancet Device

LIVONGO HEALTH, INC

Manual blood lancing device, reusable

• Primary Device ID: 00853553005141
• NIH Device Record Key: 509cf386-d1ea-41d4-9c7d-fce070785dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In Touch Lancing Device
• Version Model Number: In Touch
• Catalog Number: OFG00156
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

FDA Product Code

• FMK: Lancet, Blood

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

On-Brand Devices [In Touch Lancing Device]

• 00853553005189: Black Lancing Device
• 00853553005141: Box of 1 Lancet Device