Identity
- Trade Name
- Protocol Accessory Cart FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- Protocol Acccessory Cart FDA UDI
- Model / Reference
- 390305 FDA UDI
- Description
- Protocol Acccessory Cart FDA UDI
Identifiers
- Catalog Number
- 390305 FDA UDI
- Primary DI / UDI-DI
- 10815112020139 FDA UDI
- 510(k) Number
- K030854 FDA UDI
- FDA Product Code
- FCX FDA UDI
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Electromechanical device/system transport trolley
Protocol Accessory Cart by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030854 also covers:
- DIN 477 High Pressure Hose for CO2 — Bracco Diagnostics Inc.
- DIN 477 High Pressure Hose for CO2 — Bracco Diagnostics Inc.
- DIN 477 High Pressure Hose for CO2 — Bracco Diagnostics Inc.
- High Pressure Hose and Yoke — Bracco Diagnostics Inc.
- High Pressure Hose and Yoke — Bracco Diagnostics Inc.
- Protocol Accessory Cart — Bracco Diagnostics Inc.
- Protocol Administration Set With Flexi-Cuff Retention Tip — Bracco Diagnostics Inc.
- Protocol Administration Set With Flexi-Cuff Retention Tip — Bracco Diagnostics Inc.
- Protocol Administration Set with Small Catheter and Retention Cuff — Bracco Diagnostics Inc.
- Protocol Administration Set with Small Catheter and Retention Cuff — Bracco Diagnostics Inc.
- Protocol Colon Insufflator — Bracco Diagnostics Inc.
- Protocol Colon Insufflator Demo Unit — Bracco Diagnostics Inc.
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
- Bracco Diagnostics Inc.
Sources (1)
- FDA UDI 4d77faac-7f8d-4c2c-85d6-0951625b8cbf 36 fields · synced May 30, 2026