FreeStyle Libre

Basic Information

• Brand Name: FreeStyle Libre
• Primary DI: 00357599000479
• Version / Model: 71527
• Catalog Number: 71527
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 3
• Public Version Date: 2021-05-18
• Public Version Status: Update
• Public Device Record Key: 7f8886dd-8c0f-49fe-9cf0-60feacd0ab2f

Device Description

FreeSyle Libre Software CD

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHV	Continuous glucose monitor retrospective data analysis software	Clinical Chemistry	862.2120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58884	Self-care monitoring/reporting software	An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30357599000470	GS1	Case	8	In Commercial Distribution
Primary	00357599000479	GS1

Customer Contacts

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