Identity
- Trade Name
- Single Use Filtered Exhalation Port Circuit EUDAMEDExhalation Port Circuit FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- CKT FILTER DEP W/FEP 10PK INTL EUDAMEDFiltered Exhalation Port Circuit without Filter, International FDA UDI
- Model / Reference
- 1065836 EUDAMEDFiltered Exhalation Port Circuit without Filter, INTL FDA UDI
- Description
- Filtered Exhalation Port Circuit without Filter, International FDA UDI
Identifiers
- Catalog Number
- 1065836 FDA UDI
- Primary DI / UDI-DI
- 30606959042323 EUDAMED00606959042322 FDA UDI
- Basic UDI-DI
- B-30606959042323 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE 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
No
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
Ckt Filter Dep W/Fep 10pk Intl 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-30606959042323 | 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 a11d4e71-38bb-4450-9998-020b92ca16a5 61 fields · synced Jun 18, 2026
- FDA UDI 3fd60779-7361-4aeb-8b4d-8234ddc72ea8 36 fields · synced May 29, 2026
- EUDAMED f5923047-e67e-49ce-a972-fc93ef7406fc 61 fields · synced Jun 18, 2026