Catalog Number

500380

Brand Name

Agento™ I.C.® Silver-Coated Endotracheal Tube

Version/Model Number

500380

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071365,K071365

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

574b6a22-0c6e-4f68-a309-55f03226e053

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 25, 2016

Package DI Number

10801741067300

Quantity per Package

10

Contains DI Package

00801741067303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA