AccessGUDID - DEVICE: Clever Choice Ultrasonic Humidifier (00850002860245)

GUDID

Device Identifier (DI) Information

Brand Name: Clever Choice Ultrasonic Humidifier
Version or Model: CCH-400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50002-0860-24
Company Name: S.D.I. USA, INC.

Primary DI Number: 00850002860245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116722847 *Terms of Use

Device Description: Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Timer function and low water auto-shutoff.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16759	Room humidifier	A mains electricity (AC-powered) device intended to add moisture to ambient air, typically to prevent dryness of a patient's airways. This is a stationary device designed to be placed in one location in a room, typically in a hospital, institution, home, or office environment; it can be physically lifted and moved to another position or room. It typically consists of an electric motor, a reservoir for water, an atomizer to produce large mist particles, and a flow diverter. The water reservoir is periodically topped up with clean (preferably purified) water. Moisture is released directly into the room's atmosphere.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 13.5 Fluid Ounce
Total Volume: 400 Milliliter

Device Record Status

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