Catalog Number

-

Brand Name

Sunmed

Version/Model Number

1-7333-30

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

-

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

8cc1906f-dfb1-4ae9-9661-d1b714c4e5dc

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

20889483040505

Quantity per Package

10

Contains DI Package

10889483040508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box