Catalog Number

-

Brand Name

Trek S

Version/Model Number

047F45-AM

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

-

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

K060357,K060357

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

aeb1edbb-fae5-4fd0-b215-931c32ea0e0d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

00744229470175

Quantity per Package

6

Contains DI Package

00744229470120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton