Identity
- Trade Name
- BiPAP A40 Pro, Intl w/Heated Tube Humid EUDAMEDBiPAP A40 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- BiPAP A40 Pro, Intl w/Heated Tube Humid EUDAMEDBiPAP A40 Pro, International with Heated Tube Humidifier FDA UDI
- Model / Reference
- INX3100T19 EUDAMEDFDA UDI
- Description
- BiPAP A40 Pro, International with Heated Tube Humidifier FDA UDI
Identifiers
- Catalog Number
- INX3100T19 FDA UDI
- Primary DI / UDI-DI
- 00606959055056 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959055056 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 A40 by Respironics, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (2)
- FDA UDI 7050d6e8-5758-4f78-af63-b21038e982c8 35 fields · synced Sep 17, 2026
- EUDAMED 8cab4c50-72bf-41fe-a2bd-fb258233f449 61 fields · synced Sep 17, 2026