Livongo Refill Kit KIT00422

GUDID 00853553005264

6 bags Livongo Test Strips,4 bags Livongo Sterile Lancets, 1 Instructions for Use (English), 1 Instructions for Use (Spanish)

LIVONGO HEALTH, INC

Blood lancing device tip

• Primary Device ID: 00853553005264
• NIH Device Record Key: 186526e2-64d1-4a65-be3a-2ed6c32fe3a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Refill Kit
• Version Model Number: Livongo
• Catalog Number: KIT00422
• 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: 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: 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	00853553005264 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Livongo Refill Kit]

• 00853553005325: 4 bags/pieces Livongo Test Strips, 8 bags/pieces Livongo Sterile Lancets, 1 Instructions for Use
• 00853553005264: 6 bags Livongo Test Strips,4 bags Livongo Sterile Lancets, 1 Instructions for Use (English), 1 I