Catalog Number

-

Brand Name

AEROTRACH PLUS Anti-Static Valved Holding Chamber

Version/Model Number

101505

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

-

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,K001137

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

46fea44d-976d-4ad0-96e9-40c18956ad48

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

10762860015057

Quantity per Package

10

Contains DI Package

00762860015050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-