Catalog Number

P3500SC

Brand Name

CURAPLEX

Version/Model Number

301-0133EA

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

K894000,K894000

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

e6ee4a6e-e342-4ced-abd0-49dcce3da41e

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Package DI Number

00612223001339

Quantity per Package

15

Contains DI Package

00612223001346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS