Catalog Number

-

Brand Name

Sunmed

Version/Model Number

1-7343-35

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

bf053abe-bcf3-496c-a7af-b5ea4802808f

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

November 07, 2016

Package DI Number

20889483040666

Quantity per Package

10

Contains DI Package

10889483040669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box