Identity
- Trade Name
- IPV® In-Line Valve EUDAMEDPercussionaire FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- In-Line Valve EUDAMEDPHASITRON 5 INLINE VALVE FDA UDI
- Model / Reference
- P5-TEE EUDAMEDFDA UDI
- Description
- PHASITRON 5 INLINE VALVE FDA UDI
Identifiers
- Catalog Number
- P5-TEE FDA UDI
- Primary DI / UDI-DI
- 00849436000723 EUDAMEDFDA UDI
- Basic UDI-DI
- 849436000P5TEEE7 EUDAMED
- Direct Marketing DI
- 00849436000723 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
IPV® In-Line Valve 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 | 849436000P5TEEE7 | 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 a0588b33-a662-4c92-9365-5482dae04a4c 61 fields · synced Jun 19, 2026
- FDA UDI ae5f9bef-6200-4657-9c2a-01fe0e12685b 35 fields · synced May 30, 2026