ONE-CARE Pen Needles, 3018

GUDID 00810008211540

he 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

Insulin syringe/needle, safety
Primary Device ID00810008211540
NIH Device Record Key1cbd2eab-f985-4ee7-8f4c-28b2a088bdda
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE Pen Needles,
Version Model Number3018-ONE-CARE Pen Needles, 31G x 6mm, Blue, 100ct,
Catalog Number3018
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

Device Dimensions

Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 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
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008211519 [Primary]
GS100810008211540 [Package]
Contains: 00810008211519
Package: case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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

Devices Manufactured by MediVena, LLC

00810008211540 - ONE-CARE Pen Needles,2025-03-20he 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
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
00810008211656 - 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
00810008216385 - GLUCO-CARE Pen Needles2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216408 - GLUCO-CARE Pen Needles 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216422 - GLUCO-CARE Pen Needles2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216446 - GLUCO-CARE Pen Needles2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008216460 - GLUCO-CARE Pen Needles 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
00810008217832 - GLUCO-CARE Pen Needles2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com

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