Catalog Number

9003008

Brand Name

CUSTOMED

Version/Model Number

712057143008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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,K042683

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

62d4a6ce-6007-42dc-a9cb-c1297ce21635

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

M20890030082

Quantity per Package

10

Contains DI Package

M20890030081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10/BOX 10BOX/CS