Catalog Number

-

Brand Name

Jelco

Version/Model Number

4140

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K922445,K922445,K922445

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

0b081e69-94e3-449f-a6da-ee5922613e70

Public Version Date

April 23, 2019

Public Version Number

6

DI Record Publish Date

January 17, 2017

Package DI Number

30351688024569

Quantity per Package

40

Contains DI Package

10351688024565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE