Catalog Number

P2001CC

Brand Name

CURAPLEX

Version/Model Number

301-P2001CF

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

K880473

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

6670ba65-5ea9-4cfb-89c7-6a64f7d152ce

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-