Catalog Number

M1035991

Brand Name

Vital Signs™

Version/Model Number

M1035991

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

-

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

cd75cf89-fee3-42f7-b543-9ee0c2c4c6f1

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2021

Package DI Number

70190752136436

Quantity per Package

20

Contains DI Package

10190752136434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack