ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 2.4mm 1015

GUDID 00810008211120

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 ID00810008211120
NIH Device Record Key6b8a500b-86bc-47b1-b78d-d8fb27b10e87
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE PRO Safety Lancets, Button-Activated, 21G x 2.4mm
Version Model NumberONE-CARE PRO Safety Lancets, Button-Activated, 21G
Catalog Number1015
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
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
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
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
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
GS100810008210680 [Primary]
GS100810008211120 [Package]
Contains: 00810008210680
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

Devices Manufactured by MediVena, LLC

00810008211748 - ONE-CARE Safety Blood Collection Needles2024-10-07 ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' without Holders, Green, 48/bx, 50bx/cs
00810008211786 - ONE-CARE Safety Blood Collection Needles2024-10-07 ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' without Holders, Black, 48/bx, 50bx/cs
00810008211878 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets PRESS & LOCK, 21G x 0.75’’, Green, Luer Adapter, 12'' Tube, 50/bx, 4
00810008211908 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets PRESS & LOCK, 23G x 0.75’’, Blue, Luer Adapter, 12'' Tube, 50/bx, 4b
00810008212578 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 25G x 0.75'’, Orange, Luer Adapter, 12'' Tube, 50/bx, 4bx/cs or 20bx/c
00810008212608 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 25G x 0.75’’, Orange, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs
00810008212639 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 23G x 0.75’’, Blue, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs
00810008212660 - ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets2024-10-07 ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 21G x 0.75’’, Green, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.