WetAlert™ wireless wetness detector

Basic Information

• Brand Name: WetAlert™ wireless wetness detector
• Primary DI: 00840861101023
• Version / Model: 190507
• Company Name: Fresenius Usa, Inc.
• Labeler DUNS: 076594100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4c3a170d-90db-437b-b446-c0b9120312fa

Device Description

WetAlert™ wireless wetness detector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
ONW	Hemodialysis system for home use	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32128	Haemodialysis system blood leak detector	An electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840861101023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121421	000