Catalog Number

771453

Brand Name

3100B HFOV

Version/Model Number

771453

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"

-

For Single-Use

-

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

P890057

Product Code

LSZ

Product Code Name

VENTILATOR, HIGH FREQUENCY

Public Device Record Key

6e4e7e31-5ba4-41c2-87f4-5d8c017fd59b

Public Version Date

March 30, 2021

Public Version Number

1

DI Record Publish Date

March 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-