Catalog Number

P3000H

Brand Name

MISTIC

Version/Model Number

P3000H

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

K962534,K962534

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

e92b12ff-6fc2-4c30-b11f-d6999dd81808

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

612223300203

Quantity per Package

40

Contains DI Package

00612223300258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA