ONE-CARE OPTI Insulin Safety Syringes 2141

GUDID 00810008213971

ONE-CARE OPTI Insulin Safety Syringes are single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward to permanently lock the needle (''Click''). One-hand activation of the safety mechanism provides ultimate convenience for the user. Precise graduation enhances visibility and accurate dosing. Large barrel flanges allow for secured grip and control of insulin dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle
Primary Device ID00810008213971
NIH Device Record Key29deb711-4b66-4854-a22d-5be4a6e96d99
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE OPTI Insulin Safety Syringes
Version Model NumberONE-CARE OPTI Insulin Safety Syringes, 1mL, 29Gx 0
Catalog Number2141
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-Counterfalse

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

Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge29 Gauge
Length0.5 Inch

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
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008213964 [Primary]
GS100810008213971 [Package]
Contains: 00810008213964
Package: case [8 Units]
In Commercial Distribution

FDA Product Code

MEGSyringe, Antistick

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

On-Brand Devices [ONE-CARE OPTI Insulin Safety Syringes]

00810008214008ONE-CARE OPTI Insulin Safety Syringes are single use devices intended for safe insulin delivery.
00810008213971ONE-CARE OPTI Insulin Safety Syringes are single use devices intended for safe insulin delivery.
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