Catalog Number

11250194040

Brand Name

RespiConnect* Adapter

Version/Model Number

112501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 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

K140919,K140919

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

70875bc6-22c3-480d-a0ec-9018d7dc3fa8

Public Version Date

October 21, 2020

Public Version Number

8

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-