ONE-CARE TB Safety Syringes 2107

GUDID 00810008214114

ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. 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 dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle
Primary Device ID00810008214114
NIH Device Record Keyf323f77b-4630-4f25-8d93-876cc556f684
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE TB Safety Syringes
Version Model NumberONE-CARE TB Safety Syringes, 1mL, 28G x 0.5’’
Catalog Number2107
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

Device Dimensions

Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008214107 [Primary]
GS100810008214114 [Package]
Contains: 00810008214107
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-10-31
Device Publish Date2023-10-23

On-Brand Devices [ONE-CARE TB Safety Syringes]

00810008214176ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f
00810008214145ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f
00810008214114ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f

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