Catalog Number

DYNJAETU55

Brand Name

Medline

Version/Model Number

DYNJAETU55

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

K042683,K042683

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

500bc9e2-1170-403b-9b25-7dfbb3aa30b7

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

20888277689678

Quantity per Package

10

Contains DI Package

10888277689671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX