FreeStyle

Basic Information

• Brand Name: FreeStyle
• Primary DI: 00093815704287
• Version / Model: 70428
• Catalog Number: 70428
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-07-03
• Public Version: 1
• Public Version Date: 2018-08-03
• Public Version Status: New
• Public Device Record Key: de5ac188-4a67-46b4-8b3c-763fa36b5abe

Device Description

FreeStyle Unistik 2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FMK	Lancet, blood	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30093815704288	GS1	Case	30	In Commercial Distribution
Primary	00093815704287	GS1
Secondary	99073-0704-28	NDC/NHRIC
Unit of Use	10093815704284	GS1

Customer Contacts

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