Catalog Number

HT70PM-RU-EU

Brand Name

Newport

Version/Model Number

HT70PM-RU-EU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2018

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Public Device Record Key

0b254324-1b6c-4d84-8fb1-af48f4fa42d9

Public Version Date

August 14, 2020

Public Version Number

5

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-