iQ Blue Ventilation Mask

FDA UDI

Class II (US FDA UDI)

by Sleepnet Corporation

Identity

Trade Name: iQ Blue Ventilation Mask FDA UDI
Generic Name: CPAP/BPAP nasal mask, reusable FDA UDI
Device Name: Nasal non vented mask for use with positive pressure ventilators with exhalation valves. FDA UDI
Model / Reference: 50590 FDA UDI
Description: Nasal non vented mask for use with positive pressure ventilators with exhalation valves. FDA UDI

Identifiers

Primary DI / UDI-DI: 00814747020784 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: CPAP/BPAP nasal mask, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: CPAP/BPAP nasal mask, reusable

iQ Blue Ventilation Mask by Sleepnet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Sleepnet Corporation

Sources (1)

FDA UDI bc2914e5-5d9f-4e28-8a1c-f7cf051d935c 33 fields · synced Jun 9, 2026