Catalog Number

15200

Brand Name

Dukal

Version/Model Number

15200

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRQ

Product Code Name

Tracheostomy and nasal suctioning kit

Public Device Record Key

e1d90604-5b8b-423b-a539-010aa5141428

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20665973006431

Quantity per Package

20

Contains DI Package

00665973006437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case