Catalog Number

-

Brand Name

Portex

Version/Model Number

6947-02

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

-

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

9db35086-9fb0-489f-809f-2321b4ede7ea

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

December 13, 2016

Package DI Number

30351688056072

Quantity per Package

25

Contains DI Package

00351688056071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX