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Phasitron® 5 With Unified Connector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P5UCModel P5-UC
Identity
- Trade Name
- Phasitron® 5 With Unified Connector EUDAMEDPercussionaire FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Phasitron 5 with Unified Connector EUDAMEDFDA UDI
- Model / Reference
- P5-UC EUDAMEDP5UC EUDAMEDP5 FDA UDI
- Description
- Phasitron 5 With Unified Connector FDA UDI
Identifiers
- Catalog Number
- P5-UC FDA UDI
- Primary DI / UDI-DI
- 00849436000686 EUDAMEDFDA UDI
- Basic UDI-DI
- 849436000PHSTKS EUDAMED
- Direct Marketing DI
- 00849436000686 EUDAMED
- 510(k) Number
- K905236 FDA UDI
- FDA Product Code
- NHJ FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Phasitron® 5 With Unified Connector by Percussionaire Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 849436000PHSTKS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Percussionaire Corporation
- EUDAMED SRN
- US-MF-000036253
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED a7657d2e-bf1a-4e64-a205-4fd9c5653814 61 fields · synced Jul 13, 2026
- FDA UDI b2dc5524-9401-4d03-a7e8-ff1688287fea 36 fields · synced May 30, 2026