STAT Medical Devices

Basic Information

• Brand Name: STAT Medical Devices
• Primary DI: 00709334581215
• Version / Model: Comfort Thins Twist-Off Lancet
• Catalog Number: BTM-100
• Company Name: Stat Medical Devices, Inc.
• Labeler DUNS: 967687286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-28
• Public Version: 1
• Public Version Date: 2023-12-06
• Public Version Status: New
• Public Device Record Key: ccccf311-cee6-4fd8-8c09-529da04dfde9

Device Description

The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

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: 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
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	878.4850	2
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
61578	Manual blood lancing device, single-use	A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50709334581210	GS1	Shipper	100	In Commercial Distribution
Primary	00709334581215	GS1

Premarket Submissions

Submission Number	Supplement Number
K222034	000