Identity
- Trade Name
- Accessory Kit FDA UDI
- Generic Name
- MRI contrast medium injection system, line-powered, mobile FDA UDI
- Model / Reference
- 017381 FDA UDI
Identifiers
- Catalog Number
- 017381 FDA UDI
- Primary DI / UDI-DI
- 37630039300730 FDA UDI
- 510(k) Number
- K062449 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- MRI contrast medium injection system, line-powered, mobile 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MRI contrast medium injection system, line-powered, mobile
Accessory Kit by Bracco Injeneering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI contrast medium injection system, line-powered, mobile.
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
- MEDRAD® MRXperion MR Injection System — Bayer Medical Care Inc. · Class II
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
- SONIC SHOT GX — NEMOTO KYORINDO CO., LTD. · Class II
- MEDRAD® MRXperion MR Injection System — Bayer Medical Care Inc. · Class II
- ulricheasyINJECT Max — Ulrich GmbH & Co. KG · Class II
- MEDRAD® MRXperion MR Injection System — Bayer Medical Care Inc. · Class II
- Penetration Panel — Bracco Injeneering · Class II
Cleared under the same submission
K062449 also covers:
- Electro-Hydraulic Interconnect — Bracco Injeneering
- Empower MR Injector Head — Bracco Injeneering
- EmpowerMR® Injector System without Remote Control — Bracco Injeneering
- EmpowerMR® Injector System without Remote Control — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- FastLoad™ MR Syringe Pack — Bracco Injeneering
- Floor Stand — Bracco Injeneering
- Hydraulic Controller — Bracco Injeneering
- Penetration Panel — Bracco Injeneering
- Remote Control — Bracco Injeneering
- Remote Control — 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 8a2d1525-259b-47cb-89cb-abd40183519b 36 fields · synced May 30, 2026