Catalog Number

-

Brand Name

Portex

Version/Model Number

4646E

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

K952516,K952516

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

55a9d5b3-ebd9-47bd-bcf3-5c6e0036f431

Public Version Date

October 18, 2018

Public Version Number

4

DI Record Publish Date

December 13, 2016

Package DI Number

30351688039082

Quantity per Package

200

Contains DI Package

00351688039081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case