Duns Number:116722847
Device Description: Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Tim Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Timer function and low water auto-shutoff.
Catalog Number
50002-0860-24
Brand Name
Clever Choice Ultrasonic Humidifier
Version/Model Number
CCH-400
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)
-
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
d2ad51a3-e9b9-4afa-8045-359ff715e922
Public Version Date
November 18, 2019
Public Version Number
1
DI Record Publish Date
November 08, 2019
Package DI Number
10850002860242
Quantity per Package
12
Contains DI Package
00850002860245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |