Catalog Number

M1087562

Brand Name

Vital Signs™

Version/Model Number

M1087562

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

6e8c76d1-d968-4d78-bdf6-9304a5b6497d

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 2021

Package DI Number

20190752139586

Quantity per Package

30

Contains DI Package

10190752139589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box