Catalog Number

-

Brand Name

Kurin 21 Gauge, Standard Needle w/12" Tubing, BioMerieux Shield

Version/Model Number

M-11221

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162233,K162233,K162233

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

c7e47adc-cb19-4c6f-ad6a-36957378090c

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 28, 2018

Package DI Number

10857606008056

Quantity per Package

50

Contains DI Package

00857606008059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton