Identity
- Trade Name
- ANGIOJET FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- ULTRA SYSTEM CONSOLE, FG FDA UDI
- Model / Reference
- 105650-001 FDA UDI
- Description
- ULTRA SYSTEM CONSOLE, FG FDA UDI
Identifiers
- Catalog Number
- 105650 FDA UDI
- Primary DI / UDI-DI
- 00616258003900 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- General-purpose suction system, line-powered 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose suction system, line-powered
Angiojet by Bayer Healthcare — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Winx® — Apnicure, 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
- Bayer Healthcare
Sources (1)
- FDA UDI f19c8228-266a-4192-8414-fd375ee75d77 35 fields · synced May 30, 2026