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, remote control, power supply, transport bag and user manual FDA UDI
- Model / Reference
- SIMEOX-2 B FDA UDI
- Description
- Simeox 200 airway clearance device with installed battery, remote control, power supply, transport bag and user manual FDA UDI
Identifiers
- Catalog Number
- ACD-200B FDA UDI
- Primary DI / UDI-DI
- 36642240000928 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
- Not 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
MR Unsafe FDA UDI
Simeox 200 by Inogen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Inogen, Inc.
Sources (1)
- FDA UDI a24e1e76-1221-4dd0-9ece-ce336100c60f 36 fields · synced May 30, 2026