ONE-CARE Insulin Safety Syringes 2101

GUDID 00810008211557

ONE-CARE Insulin Safety Syringes are sterile, single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). 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 ID00810008211557
NIH Device Record Key804b368e-bed2-4a0f-a70e-6a77be4ef0bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE Insulin Safety Syringes
Version Model NumberONE-CARE Insulin Safety Syringes, 1mL, 29G x 0.5 i
Catalog Number2101
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
GS100810008211557 [Package]
Contains: 10810008210014
Package: case [10 Units]
In Commercial Distribution
GS110810008210014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

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 Insulin Safety Syringes]

00810008211564ONE-CARE® Insulin Safety Syringes are single use devices intended for safe insulin delivery. Th
00810008211557ONE-CARE Insulin Safety Syringes are sterile, single use devices intended for safe insulin deliv
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