Identity
- Trade Name
- SIMEOX 200 FDA UDI
- Generic Name
- Vacuum-assisted airway secretion-clearing system FDA UDI
- Device Name
- Simeox 200 airway clearance device with installed battery FDA UDI
- Model / Reference
- ACD-200B FDA UDI
- Description
- Simeox 200 airway clearance device with installed battery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664224000092 FDA UDI
- FDA Product Code
- SDT FDA UDI
- GMDN Term
- Vacuum-assisted airway secretion-clearing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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: Vacuum-assisted airway secretion-clearing system
Simeox 200 by Physio-Assist — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-assisted airway secretion-clearing system.
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- TUB25 — PHYSIO-ASSIST
- SIMEOX 200 — PHYSIO-ASSIST · Class II
- TUB10 — PHYSIO-ASSIST · Class II
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
- Physio-Assist
Sources (1)
- FDA UDI cf896156-993c-4894-bfd1-c5b89c1993c8 34 fields · synced May 29, 2026