BiPAP

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: BiPAP FDA UDI
Generic Name: Home BPAP unit FDA UDI
Device Name: BiPAP Pro Bilevel System with Bi-Flex, Humidifier, and SD Card, China FDA UDI
Model / Reference: CN657HS FDA UDI
Description: BiPAP Pro Bilevel System with Bi-Flex, Humidifier, and SD Card, China FDA UDI

Identifiers

Catalog Number: CN657HS FDA UDI
Primary DI / UDI-DI: 00606959001053 FDA UDI
510(k) Number: K091319 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Home BPAP unit 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Home BPAP unit

BiPAP by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091319 also covers:

BiPAP — Respironics, Inc.
BiPAP — Respironics, Inc.
REMstar — Respironics, Inc.
REMstar — Respironics, Inc.
REMstar — Respironics, Inc.
REMstar — Respironics, Inc.
REMstar — Respironics, Inc.
System One, 50 Series — Respironics, Inc.
System One, 50 Series — Respironics, Inc.

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: Respironics, Inc.

Sources (1)

FDA UDI e43ee3d3-ccc3-4d76-a196-2957021eb4e3 37 fields · synced May 30, 2026