Catalog Number

10150594010

Brand Name

AEROTRACH PLUS Anti-Static Valved Holding Chamber

Version/Model Number

101505

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 03, 2020

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

K001137,K001137

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

435d2fac-80a7-4d89-9edd-8cb4051d8ab1

Public Version Date

January 06, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-