FreeStyle Lite

Basic Information

• Brand Name: FreeStyle Lite
• Primary DI: 00699073708175
• Version / Model: 70817
• Catalog Number: 70817
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: f1848573-2ff8-4935-a0c9-ff196ce37afc

Device Description

FreeStyle Lite Blood Glucose Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFR	Glucose dehydrogenase, glucose	Clinical Chemistry	862.1345	2
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62643	Multiple clinical chemistry analyte monitoring system IVD, home-use	A collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30699073708176	GS1	Case	16	In Commercial Distribution
Primary	00699073708175	GS1
Unit of Use	10699073708172	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092602	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 86 Degrees Fahrenheit