Catalog Number

-

Brand Name

INOmax

Version/Model Number

91425

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131686,K131686

Product Code

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

1fb0033b-9b14-4ca9-a398-1f9a8a1e8bf0

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Package DI Number

10810055280268

Quantity per Package

5

Contains DI Package

00810055280261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-