Catalog Number

11250194040

Brand Name

RespiConnect* Adapter

Version/Model Number

112501

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

K140919,K140919,K140919

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

a9ac9e55-29a1-4508-81f5-99c911311479

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

February 19, 2020

Package DI Number

10762860125015

Quantity per Package

40

Contains DI Package

00762860125018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-