GLUCO-CARE Safety Lancets, Contact-Activated, 21Gx 1.8mm

Basic Information

• Brand Name: GLUCO-CARE Safety Lancets, Contact-Activated, 21Gx 1.8mm
• Primary DI: 00810008214428
• Version / Model: GLUCO-CARE Safety Lancets, Contact-Activated, 21Gx 1.8mm
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-26
• Public Version: 1
• Public Version Date: 2024-03-05
• Public Version Status: New
• Public Device Record Key: a4c292da-5a21-4a9a-8739-f478e76534fa

Device Description

MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. GLUCO-CARE Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap, then pull it out, STEP 2 Press the color-coded main housing to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
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	00810008214497	GS1	case	50	In Commercial Distribution
Primary	00810008214428	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge
Length	1.8	Millimeter

Storage Conditions

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