Catalog Number

-

Brand Name

1160 AIR DISS Regulator TAV

Version/Model Number

10-09841-XX-01

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

K152664

Product Code

ONZ

Product Code Name

Mechanical Ventilator

Public Device Record Key

8c948149-756f-47e6-91c0-622d3c595f13

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-