Catalog Number

ETT-P22-80

Brand Name

Medis

Version/Model Number

ETT-P22-80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K160694,K160694,K160694

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

56bc3104-ee61-473c-9c99-0b2822e293d2

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 11, 2020

Package DI Number

16920687301003

Quantity per Package

10

Contains DI Package

06920687301006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box