Dario 100 Sterile Lancets

Basic Information

• Brand Name: Dario 100 Sterile Lancets
• Primary DI: 00850065006222
• Version / Model: 1121-05
• Company Name: LABSTYLE INNOVATION LTD
• Labeler DUNS: 600039072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-10
• Public Version: 1
• Public Version Date: 2021-08-18
• Public Version Status: New
• Public Device Record Key: ad881d90-bd33-48a1-a801-d6ed6d72a672

Device Description

The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancing device cover prevents the user from unintentional punctures.

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: Yes
• Has Serial Number: No
• 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
FMK	Lancet, Blood	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
Primary	00850065006222	GS1