WaterPAP PRO Starter Kit

FDA UDI

Class II (US FDA UDI)

by Airways Development, LLC

Identity

Trade Name: WaterPAP PRO Starter Kit FDA UDI
Generic Name: Mechanical expiratory valve, single-use FDA UDI
Device Name: WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use. FDA UDI
Model / Reference: WP-7805 FDA UDI
Description: WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use. FDA UDI

Identifiers

Primary DI / UDI-DI: 90862146000336 FDA UDI
FDA Product Code: BYE FDA UDI
GMDN Term: Mechanical expiratory valve, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5965 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mechanical expiratory valve, single-use

WaterPAP PRO Starter Kit by Airways Development, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Mechanical expiratory valve, single-use.

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Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
Expiratory valve set — HAMILTON MEDICAL, INC. · Class I
WaterPAP PRO — Airways Development, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Airways Development, LLC

Sources (1)

FDA UDI cf393c32-d31e-4c5c-81bc-f6973062fa95 33 fields · synced May 30, 2026