AccessGUDID - DEVICE: Waterpik RainFall+ with PowerPulse (00073950272209)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik RainFall+ with PowerPulse
Version or Model: XEM-639E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XEM-639E
Company Name: WATER PIK, INC.

Primary DI Number: 00073950272209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Fix mount drencher shower head, brushed nickel

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):	Yes
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?
34661	External manual massager, home-use	A manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYG	Massager, Therapeutic, Manual

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
No Device Sizes

Device Record Status

Public Device Record Key: a883af34-54bd-4ac4-a419-90b0bcbfdf1b
Public Version Date: May 03, 2022
Public Version Number: 3
DI Record Publish Date: July 27, 2020