← Back to catalogue
(10) Disposable Proximal Pressure Line Assembly
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 312112
Identity
- Trade Name
- (10) Disposable Proximal Pressure Line Assembly EUDAMEDBiPAP FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- BiPAP Disp Circuits EUDAMEDDisp Prox Pres Line Assy,Bx10 FDA UDI
- Model / Reference
- 312112 EUDAMEDFDA UDI
- Description
- Disp Prox Pres Line Assy,Bx10 FDA UDI
Identifiers
- Catalog Number
- 312112 FDA UDI
- Primary DI / UDI-DI
- 00606959054158 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959054158 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
(10) Disposable Proximal Pressure Line Assembly 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-00606959054158 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 66c9f56f-d127-47b2-983f-68a7ef8e9c59 61 fields · synced Jul 22, 2026
- FDA UDI 7218a215-0c9d-473d-a247-ea14311d5390 36 fields · synced May 30, 2026
- EUDAMED 01504782-8283-4246-a9df-b5d833f7763d 61 fields · synced Jul 22, 2026