Identity
- Trade Name
- BCI FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Model / Reference
- 3311 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019517059199 FDA UDI
- 510(k) Number
- K970209 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric infusion pump administration set, single-use
Bci by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric infusion pump administration set, single-use.
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- Alaris, SmartSite — BD Switzerland Sàrl · Class II
- Clear-View Multi-site Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC · Class II
- Infusomat® — B. BRAUN MEDICAL INC. · Class II
- Alaris — BD Switzerland Sàrl · Class II
Cleared under the same submission
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI c227a9d3-582c-4930-86f7-174724c54236 33 fields · synced Jun 8, 2026