Catalog Number

-

Brand Name

Jelco

Version/Model Number

982306L-2

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

K081229,K081229,K081229

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

f046b044-5a46-41a3-b4d4-b2a430213f96

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

February 10, 2017

Package DI Number

55019517080948

Quantity per Package

200

Contains DI Package

35019517080944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE