Catalog Number

-

Brand Name

Carex Health Brands

Version/Model Number

FGR11000 0000

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

07eb4e02-30f9-4773-9c50-3b802a4c0aea

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Package DI Number

30023601061103

Quantity per Package

6

Contains DI Package

00023601061102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA