Catalog Number

-

Brand Name

Portex

Version/Model Number

100/399/216

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

K051524,K051524

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

9ac95acf-9c59-4a10-9d44-8aeda0326b58

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 03, 2018

Package DI Number

10351688068132

Quantity per Package

50

Contains DI Package

00351688068135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX