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Disposable Proximal Pressure Line, 84 in (213.36 cm)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 312121
Identity
- Trade Name
- Disposable Proximal Pressure Line, 84 in (213.36 cm) EUDAMEDBiPAP FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- BiPAP Disp Circuits EUDAMED
- Model / Reference
- 312121 EUDAMEDDisposable Proximal Pressure Line, 84 in FDA UDI
Identifiers
- Catalog Number
- 312121 FDA UDI
- Primary DI / UDI-DI
- 00606959054165 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959054165 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
Disposable Proximal Pressure Line, 84 in (213.36 cm) by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00606959054165 | 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 (3)
- EUDAMED 5a5fb435-2bc5-4e62-86b4-5cb74b1ef9a6 61 fields · synced Jun 19, 2026
- FDA UDI 73130658-f555-45b0-ab66-5f0158f9eab0 34 fields · synced May 29, 2026
- EUDAMED 79b09cf3-fb3d-4a5e-9adb-dfb23f7d9129 61 fields · synced Jun 19, 2026