ONE-CARE Pen Needles 3014

GUDID 00810008215531

The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices

MediVena, LLC

Autoinjector needle
Primary Device ID00810008215531
NIH Device Record Key93b9b39b-0763-490a-bbb5-016eb56b63d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE Pen Needles
Version Model Number3014-ONE-CARE Pen Needles 32G x 6mm, Yellow, 100/b
Catalog Number3014
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 Datetrue
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

Device Dimensions

Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008215524 [Primary]
GS100810008215531 [Package]
Contains: 00810008215524
Package: case [50 Units]
In Commercial Distribution

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

On-Brand Devices [ONE-CARE Pen Needles]

00810008211632The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008215531The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008211175The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008211656he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin

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