Identity
- Trade Name
- Percussionaire FDA UDI
- Generic Name
- Stationary pneumatic high-frequency ventilator respiration monitor FDA UDI
- Device Name
- Unit ASSY, Model F00007-1, WFA Monitron II FDA UDI
- Model / Reference
- F00007-1 FDA UDI
- Description
- Unit ASSY, Model F00007-1, WFA Monitron II FDA UDI
Identifiers
- Catalog Number
- S00015-2 FDA UDI
- Primary DI / UDI-DI
- 00849436000662 FDA UDI
- 510(k) Number
- K905235 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Stationary pneumatic high-frequency ventilator respiration monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Stationary pneumatic high-frequency ventilator respiration monitor
Percussionaire by Percussionaire Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary pneumatic high-frequency ventilator respiration monitor.
- Percussionaire — Percussionaire Corporation · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Percussionaire Corporation
Sources (1)
- FDA UDI 26ba7fa1-483b-4a26-9800-1328124ff65f 36 fields · synced May 30, 2026