Catalog Number

1114

Brand Name

PRIMEAIRE

Version/Model Number

1114

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

K992722,K992722

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

71303c12-74e6-41f4-9598-0293f0fa766f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10383480000058

Quantity per Package

10

Contains DI Package

00383480000051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case