Catalog Number

9030

Brand Name

LifePort

Version/Model Number

3.0 mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

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

P850064,P850064

Product Code

LSZ

Product Code Name

Ventilator, High Frequency

Public Device Record Key

84454e9c-3046-42ab-b601-eb5cdbc17c47

Public Version Date

August 29, 2018

Public Version Number

4

DI Record Publish Date

December 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-