ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm 1014

GUDID 00810008211045

MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO 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 by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.

MediVena, LLC

Manual blood lancing device, single-use
Primary Device ID00810008211045
NIH Device Record Key07a3cf8c-f8b6-40b2-9caa-aadb3257916e
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm
Version Model NumberONE-CARE PRO Safety Lancets, Button-Activated, 21G
Catalog Number1014
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
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
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
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer
Needle Gauge21 Gauge
Length1.8 Micrometer

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
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
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
GS100810008210673 [Primary]
GS100810008211045 [Package]
Contains: 00810008210673
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 Date2024-03-05
Device Publish Date2024-02-26

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00810008211540 - ONE-CARE Pen Needles,2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp
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