Identity
- Trade Name
- Bottle Spike Type A FDA UDI
- Generic Name
- Contrast medium injection system syringe FDA UDI
- Device Name
- Bottle Spike Type A FDA UDI
- Model / Reference
- 640458 FDA UDI
- Description
- Bottle Spike Type A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17630039301498 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
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Contrast medium injection system syringe
Bottle Spike Type A by Bracco Injeneering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Contrast medium injection system syringe.
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
Cleared under the same submission
K151048 also covers:
- CT Exprès Patient Set — ACIST Medical Systems, Inc.
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bracco Injeneering
Sources (1)
- FDA UDI b9b3863c-f47a-47bd-bf76-57fe7671e012 35 fields · synced May 30, 2026