GLUCO-CARE Pen Needles 3039

GUDID 00810008216408

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 device

MediVena, LLC

Autoinjector needle
Primary Device ID00810008216408
NIH Device Record Key92b164dc-f13c-4ae5-8694-24fa085a2e11
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLUCO-CARE Pen Needles
Version Model Number3039-GLUCO-CARE Pen Needles 31G x 8mm, Orange, 100
Catalog Number3039
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 Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 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
GS100810008216392 [Primary]
GS100810008216408 [Package]
Contains: 00810008216392
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 Date2025-03-20
Device Publish Date2025-03-12

On-Brand Devices [GLUCO-CARE Pen Needles ]

00810008217795The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217771The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216347The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216323The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217818The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217917The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217894The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217870The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217856The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008217832The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216460The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216446The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216422The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216408The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
00810008216385The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin

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