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BiPap Vision Disposable Circuit, Single
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 582072Model Disposable Circuits
Identity
- Trade Name
- BiPap Vision Disposable Circuit, Single EUDAMEDBiPAP FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- BiPAP Vision Disposable Circuit Single FDA UDI
- Model / Reference
- Disposable Circuits EUDAMED582072 EUDAMED00 FDA UDI
- Description
- BiPAP Vision Disposable Circuit Single FDA UDI
Identifiers
- Catalog Number
- 582072 FDA UDI
- Primary DI / UDI-DI
- 00606959042353 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959042353 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- R02010402 NIV CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPap Vision Disposable Circuit, Single by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959042353 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 5d748e1b-a292-47e0-b63e-37b120a5afaa 61 fields · synced Jun 18, 2026
- FDA UDI 1df3aaf6-9fcb-4349-b054-c598e3d838a9 36 fields · synced May 30, 2026