Catalog Number

772793

Brand Name

3100 HFOV

Version/Model Number

772793

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

Yes

Prescription Use (Rx)

-

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

590ae81f-47b6-4242-a537-988a16b216ad

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-