Catalog Number

MS-121

Brand Name

Ulti-MistHME/F ICU

Version/Model Number

MS-121

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"

Yes

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

-

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

d302adb0-eb44-46a0-9730-1af39e21546a

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

00612649181813

Quantity per Package

50

Contains DI Package

00612649205199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-