FreeStyle Libre 2

Basic Information

• Brand Name: FreeStyle Libre 2
• Primary DI: 00357599800000
• Version / Model: 71992
• Catalog Number: 71992
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-31
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0b85c124-3b28-4cd5-9cdf-d71d5eb89a33

Device Description

FreeStyle Libre 2 Flash Glucose Monitoring System Sensor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QLG	Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems	Clinical Chemistry	862.1355	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44611	Percutaneous interstitial-fluid glucose monitoring system, electrochemical	An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30357599800001	GS1	Case	1	In Commercial Distribution
Primary	00357599800000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193371	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 82 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity