Unilet ComforTouch

Basic Information

• Brand Name: Unilet ComforTouch
• Primary DI: 00384700455019
• Version / Model: AT 0455
• Company Name: OWEN MUMFORD USA INCORPORATED
• Labeler DUNS: 803401454
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-01-11
• Public Version: 1
• Public Version Date: 2023-01-19
• Public Version Status: New
• Public Device Record Key: ed04f988-5cbb-4b37-b219-9b6fecf77b5a

Device Description

Unilet ComforTouch Thin Lancets 23G 100 count

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: 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

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	00384700455033	GS1	Case	200	In Commercial Distribution
Primary	00384700455019	GS1
Unit of Use	00384700455002	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge