GLUCO-CARE PLUS Pen Needles 3023

GUDID 00810008214640

Sterile, single-use pen needles, 32 Gauge, 5mm (3/16") length, extra-thin wall

MediVena, LLC

Autoinjector needle
Primary Device ID00810008214640
NIH Device Record Key70c6baf9-afa9-4d9e-b821-2614be78b0f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLUCO-CARE PLUS Pen Needles
Version Model Number3023 GLUCO-CARE PLUS Pen Needles, 32G x 5mm
Catalog Number3023
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
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com

Device Dimensions

Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter
Needle Gauge32 Gauge
Length5 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008214633 [Primary]
GS100810008214640 [Package]
Contains: 00810008214633
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 Date2024-10-07
Device Publish Date2024-09-27

On-Brand Devices [GLUCO-CARE PLUS Pen Needles]

00810008214190Sterile, single-use pen needles, 32 Gauge, 4mm (5/32") length, extra-thin wall
00810008214688Sterile, single-use pen needles, 33 Gauge, 4mm (5/32") length, extra-thin wall
00810008214664Sterile, single-use pen needles, 32 Gauge, 6mm (1/4") length, extra-thin wall
00810008214640Sterile, single-use pen needles, 32 Gauge, 5mm (3/16") length, extra-thin wall

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