Identity
- Trade Name
- CT Exprès™ - Bottle Spike Type A (30 mm) FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Model / Reference
- 640458 FDA UDI
Identifiers
- Catalog Number
- 640458 FDA UDI
- Primary DI / UDI-DI
- 17630039300002 FDA UDI
- 510(k) Number
- K151048 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- Contrast medium injection system syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CT Exprès™ - Bottle Spike Type A (30 mm) by Bracco Injeneering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151048 also covers:
- CT Exprès Patient Set — ACIST Medical Systems, Inc.
- Bottle Spike Type A — Bracco Injeneering
- CT Expres™ 3D — Bracco Injeneering
- CT Exprès™ - Bottle Insulator — Bracco Injeneering
- CT Exprès™ - Control Panel — Bracco Injeneering
- CT Exprès™ - Day Set III HP — Bracco Injeneering
- CT Exprès™ - Hand Switch — Bracco Injeneering
- CT Exprès™ - Injector Unit — Bracco Injeneering
- CT Exprès™ - Patient Set — Bracco Injeneering
- Day Set III HP — Bracco Injeneering
- Day Set III HP — Bracco Injeneering
- Patient Set — Bracco Injeneering
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 Injeneering
Sources (1)
- FDA UDI 881ab247-e764-47b2-8679-3b907ba2effa 37 fields · synced Jun 8, 2026