Catalog Number

47835

Brand Name

Argyle

Version/Model Number

47835

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"

-

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

-

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

36b4eaf0-ea9f-4ca5-848a-06d61e304090

Public Version Date

June 17, 2019

Public Version Number

7

DI Record Publish Date

August 28, 2015

Package DI Number

20884527000262

Quantity per Package

20

Contains DI Package

10884527000265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE