DRYBUDDY

Basic Information

• Brand Name: DRYBUDDY
• Primary DI: 00852930006313
• Version / Model: DBFL3
• Catalog Number: DBFL3
• Company Name: ENURESIS SOLUTIONS, LLC
• Labeler DUNS: 932984375
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-09
• Public Version: 2
• Public Version Date: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: 7a7dad4e-1dc8-456a-b87e-2dee5676f19d
• Distribution End Date: 2022-12-31

Device Description

DryBuddyFLEX 3 3rd Gen. Long-Range True Wireless Bedwetting Alarm System with Magnetic Sensor & Remote.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	876.2040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11588	Incontinence sensor/alarm	A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852930006313	GS1