ONE-CARE Safety Blood Collection Needles 5021-H

GUDID 00810008212936

ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' with Holders, Green, 100/bx, 5bx/cs

MediVena, LLC

Blood collection tube holder/needle
Primary Device ID00810008212936
NIH Device Record Key310b0df5-674b-47b9-914d-a59b8ae6fc5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE Safety Blood Collection Needles
Version Model Number5021-H ONE-CARE Safety Blood Collection Needles 21
Catalog Number5021-H
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 Perscriptiontrue
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

Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch
Needle Gauge21 Gauge
Length1.25 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008212929 [Primary]
GS100810008212936 [Package]
Contains: 00810008212929
Package: Box [100 Units]
In Commercial Distribution
GS100810008212943 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-07
Device Publish Date2024-09-27

On-Brand Devices [ONE-CARE Safety Blood Collection Needles]

00810008212950ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' with Holders, Yellow, 100/bx, 5bx/cs
00810008212936ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' with Holders, Green, 100/bx, 5bx/cs
00810008212905ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders, Black, 100/bx, 5bx/cs
00810008212875ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' without Holders, Yellow, 48/bx, 50bx/cs
00810008211786ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' without Holders, Black, 48/bx, 50bx/cs
00810008211748ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' without Holders, Green, 48/bx, 50bx/cs

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