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BiPAP System One 60 Series

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
BiPAP System One 60 Series FDA UDI
Generic Name
Home BPAP unit FDA UDI
Device Name
BiPAP Auto BiFlex with Heated Tube Humidifier System One 60 Series, AHP FDA UDI
Model / Reference
BiPAP Auto BiFlex, w/HTD Humid, System One 60 Srs, AHP FDA UDI
Description
BiPAP Auto BiFlex with Heated Tube Humidifier System One 60 Series, AHP FDA UDI

Identifiers

Catalog Number
AH760TS FDA UDI
Primary DI / UDI-DI
00606959005990 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Home BPAP unit

BiPAP System One 60 Series by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home BPAP unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 99b2528a-10b0-4d66-bcd3-527f9ddce489 36 fields · synced May 31, 2026