CareLiving Lancing Device+100 Lancets

Basic Information

• Brand Name: CareLiving Lancing Device+100 Lancets
• Primary DI: 00383568100413
• Version / Model: Lancing Device+Lancets
• Catalog Number: 83568-1004-13
• Company Name: Care Living Diagnostics Inc.
• Labeler DUNS: 125354643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-10
• Public Version: 2
• Public Version Date: 2024-04-26
• Public Version Status: Update
• Public Device Record Key: f2c82c78-4f96-430a-b85b-3e6336d9e818

Device Description

1 x CARELIVING Lancing device, 100 x 30 Gauge Lancets.1 x User Guide,LESS PAINFUL,STRONG PENETRATION,12 OPTIONAL DEPTH SETTINGS,EASY-TO-USE LANCET INJECTOR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
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
37243	Manual blood lancing device, reusable	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device.	No	Active
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00383568100413	GS1

Premarket Submissions

Submission Number	Supplement Number
K232330	000