Catalog Number

-

Brand Name

SinuStar

Version/Model Number

085F77-LCS

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"

-

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

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

8c2c22ff-ffb3-4ae4-a3fc-7e1a90dbee40

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 17, 2016

Package DI Number

00744229850335

Quantity per Package

6

Contains DI Package

00744229850311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton