ONE-CARE Safety Lancets

Basic Information

• Brand Name: ONE-CARE Safety Lancets
• Primary DI: 00810008210123
• Version / Model: 1104 ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, Lime, 100/bx, 20bx/cs
• Catalog Number: 1104
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-16
• Public Version: 1
• Public Version Date: 2025-02-24
• Public Version Status: New
• Public Device Record Key: 38f9d54c-d865-4073-9411-2b5b6712ffc3

Device Description

ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure.

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: Yes
• 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
FMK	Single Use Only Blood Lancet With 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	00810008210130	GS1	Case	20	In Commercial Distribution
Primary	00810008210123	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222376	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge
Length	1.8	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit