Identity
- Trade Name
- IPV 1 EUDAMEDPercussionaire FDA UDI
- Generic Name
- Portable pneumatic high-frequency ventilator FDA UDI
- Device Name
- Phasitron 5 with Unified Connector EUDAMEDIPV1, Airway Clearance, Dual Gas FDA UDI
- Model / Reference
- P5-UC EUDAMEDS00065 EUDAMEDIPV1 FDA UDI
- Description
- IPV1, Airway Clearance, Dual Gas FDA UDI
Identifiers
- Catalog Number
- S00065 FDA UDI
- Primary DI / UDI-DI
- 00849436000679 EUDAMEDFDA UDI
- Basic UDI-DI
- 849436000PHSTKS EUDAMED
- 510(k) Number
- K905236 FDA UDI
- FDA Product Code
- NHJ FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Portable pneumatic high-frequency ventilator 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulmonary function analysis system, adult
Ipv 1 by Percussionaire Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 3c75f688-e618-4ac3-9ffb-3e45bb1d7e42 61 fields · synced Jun 19, 2026
- FDA UDI 4ead1a94-3ecb-4a35-9a49-3d3a7cb8f84d 36 fields · synced May 30, 2026