WaterPAP

Basic Information

• Brand Name: WaterPAP
• Primary DI: 00862146000302
• Version / Model: WP-7700
• Company Name: AIRWAYS DEVELOPMENT COMPANY LLC
• Labeler DUNS: 109509435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 4
• Public Version Date: 2018-11-05
• Public Version Status: Update
• Public Device Record Key: eced8ea7-befc-4c83-972d-f3fa59c90ffe

Device Description

Positive Airway pressure device

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• 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
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46824	Mechanical expiratory valve, single-use	A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit or system to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20862146000306	GS1	Case	4	In Commercial Distribution
Package	10862146000309	GS1	Box	10	In Commercial Distribution
Primary	00862146000302	GS1