Catalog Number

CSM2

Brand Name

Nasal-Aire II

Version/Model Number

CSM2

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

Yes

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

-

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

b38eaa27-c804-4939-98ce-09860373b9ef

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

50833224004012

Quantity per Package

3

Contains DI Package

30833224004018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-