ONE-CARE PLUS Safety Lancets 1005

GUDID 00810008210314

Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.4 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience.

MediVena, LLC

Manual blood lancing device, single-use
Primary Device ID00810008210314
NIH Device Record Key688f499d-f495-481e-80af-af7e538b7460
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE PLUS Safety Lancets
Version Model Number1005 ONE-CARE PLUS Safety Lancets 21G x 2.4mm, Ext
Catalog Number1005
Company DUNS080740980
Company NameMediVena, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com

Device Dimensions

Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter
Needle Gauge21 Gauge
Length2.4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008210215 [Primary]
GS100810008210314 [Package]
Contains: 00810008210215
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-16

On-Brand Devices [ONE-CARE PLUS Safety Lancets]

00810008210307Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.8 mm are designed with an ergonomic body
00810008210314Contact-activated ONE-CARE PLUS Safety Lancets 21G x 2.4 mm are designed with an ergonomic body
00810008210321Contact-activated ONE-CARE PLUS Safety Lancets 21G x 1.8 mm are designed with an ergonomic body
00810008210338Contact-activated ONE-CARE PLUS Safety Lancets 25G x 1.8 mm are designed with an ergonomic body
00810008210345Contact-activated ONE-CARE PLUS Safety Lancets 28G x 1.8 mm are designed with an ergonomic body
00810008210352Contact-activated ONE-CARE PLUS Safety Lancets 30G x 1.5mm are designed with an ergonomic body f

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