Catalog Number

-

Brand Name

Portex

Version/Model Number

A4195-22

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

K965017,K965017

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

6f05237b-b43c-40a4-9755-892bffcd0d5f

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

30351688082439

Quantity per Package

10

Contains DI Package

20351688082432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE