Catalog Number

-

Brand Name

Sunmed

Version/Model Number

1-7330-50

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

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

78c3905d-b80c-40cb-a804-2f9401c18560

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

20889483040475

Quantity per Package

10

Contains DI Package

10889483040478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box