Catalog Number

-

Brand Name

PROCARE

Version/Model Number

PCCM-840

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

Humidifier, Non-Direct Patient Interface (Home-Use)

Public Device Record Key

ed488300-e460-41cd-8025-f59e6cca5c37

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

October 01, 2018

Package DI Number

70328785108407

Quantity per Package

2

Contains DI Package

00328785008401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE