Catalog Number

-

Brand Name

Portex

Version/Model Number

1140

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

K993282,K993282

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

663bdbab-4244-49e2-8730-9667cf4a1dec

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

30351688517030

Quantity per Package

40

Contains DI Package

10351688517036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE