FreeStyle

Basic Information

• Brand Name: FreeStyle
• Primary DI: 00699073130013
• Version / Model: 70469
• Catalog Number: 70469
• Company Name: ABBOTT DIABETES CARE INC
• Labeler DUNS: 966390890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-06-15
• Public Version: 2
• Public Version Date: 2022-11-22
• Public Version Status: Update
• Public Device Record Key: 0dc427fc-8196-489e-94f7-c9e1ad9f8e32

Device Description

FreeStyle Lancets 28 Gauge

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: 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
QRK	Single use only blood lancet without an integral sharps injury prevention feature	General, Plastic Surgery	878.4850	2
QRL	Multiple use blood lancet for single patient use only	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30699073130014	GS1	Case	24	In Commercial Distribution
Primary	00699073130013	GS1
Secondary	99073-0130-01	NDC/NHRIC
Unit of Use	10699073130010	GS1

Customer Contacts

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