Livongo Test Strips - Mexico OFG10353

GUDID 00853553005738

OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.

LIVONGO HEALTH, INC

Glucose IVD, reagent

• Primary Device ID: 00853553005738
• NIH Device Record Key: ddd6419d-9b59-4d72-8aa7-729ea5256fe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Test Strips - Mexico
• Version Model Number: Livongo
• Catalog Number: OFG10353
• 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: 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: 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
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

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: 2022-09-28
• Device Publish Date: 2022-09-20

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• 00810079260058 - Teladoc Health, Inc: 2023-09-04 WM1500 Scale, BG95-M2
• 00853553005646 - Teladoc Health, Inc: 2023-09-04 KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
• 00853553005738 - Livongo Test Strips - Mexico: 2022-09-28OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.
• 00853553005738 - Livongo Test Strips - Mexico: 2022-09-28 OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.
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