Catalog Number

DYNJAAHME23

Brand Name

Medline

Version/Model Number

DYNJAAHME23

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

K033008,K033008

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

0915f1d6-9d51-4bca-8f0d-5ce269f46b0b

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

July 14, 2021

Package DI Number

20884389975890

Quantity per Package

12

Contains DI Package

10888277333383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE