Identity
- Trade Name
- BiPAP A30 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- BiPAP A30 Ventilator with Humidifier, Australia FDA UDI
- Model / Reference
- BiPAP A30 Ventilator with Humidifier, AU FDA UDI
- Description
- BiPAP A30 Ventilator with Humidifier, Australia FDA UDI
Identifiers
- Catalog Number
- 1111146 FDA UDI
- Primary DI / UDI-DI
- 00606959039322 FDA UDI
- 510(k) Number
- K113053 FDA UDI
- FDA Product Code
- MNS FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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: Portable electric ventilator
BiPAP A30 by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable electric ventilator.
- VOCSN Patient Breathing Package — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN O2 Low Pressure Inlet — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN Internal Bacterial Filter — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN High Flow Kit — VENTEC LIFE SYSTEMS, INC. · Class II
- Philips Respironics — Respironics California, Inc. · Class II
- VOCSN Patient Breathing Package — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN Humidifier Bypass — VENTEC LIFE SYSTEMS, INC. · Class II
Cleared under the same submission
K113053 also covers:
- BiPAP — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — Respironics, Inc.
- BiPAP A30 — 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 ce542e8b-745f-4643-8b3f-30b1d41d198c 37 fields · synced May 30, 2026