ONE-CARE 3350

GUDID 00810008212080

ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover and lock the needle to minimize the risk of accidental needle sticks.

MediVena, LLC

Autoinjector needle
Primary Device ID00810008212080
NIH Device Record Key889c027c-0c8c-414d-b376-43e381515676
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE
Version Model NumberONE-CARE DUO Safety Pen Needles
Catalog Number3350
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

Device Dimensions

Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter
Needle Gauge30 Gauge
Length5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008212080 [Primary]
GS100810008214299 [Package]
Package: Case [8 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 Date2023-10-06
Device Publish Date2023-09-28

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00810008210451ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fr
00810008210499ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitat
00810008210031ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose i
00810008212103ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically
00810008211939ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded a
00810008212080ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutan

Trademark Results [ONE-CARE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONE-CARE
ONE-CARE
88267775 not registered Live/Pending
MediVena, LLC
2019-01-18

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