Identity
- Trade Name
- ET CONTROL OPTION FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- ET CONTROL OPTION FDA UDI
- Model / Reference
- AISYS CS2 FDA UDI
- Description
- ET CONTROL OPTION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278579157 FDA UDI
- PMA Number
- P210018 FDA UDI
- FDA Product Code
- QSF FDA UDI
- GMDN Term
- Anaesthesia workstation, general-purpose FDA UDI
Classification
- Device Class
- Class III 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
No
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
No
FDA UDI
Category: Anaesthesia workstation, general-purpose
Et Control Option by Datex-Ohmeda Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- A9800 Anesthesia Workstation — ORICARE INC. · 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 III | Pending data |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
Sources (1)
- FDA UDI e81abc9c-e901-4620-a16e-5263946563e6 34 fields · synced May 30, 2026