Identity
- Trade Name
- Medex FDA UDI
- Generic Name
- Contrast medium injection system hand controller kit FDA UDI
- Model / Reference
- MX837E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688504746 FDA UDI
- 510(k) Number
- K790314 FDA UDI
- FDA Product Code
- FPB FDA UDI
- GMDN Term
- Contrast medium injection system hand controller kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Contrast medium injection system hand controller kit
Medex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Contrast medium injection system hand controller kit.
- AngioTouch® Kit — ACIST Medical Systems, Inc. · Class II
- MEDRAD® MRXperion MR Injection System Handswitch — Bayer Medical Care Inc. · Class II
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Multi-Patient Disposable Hand Controller — Bayer Medical Care Inc. · Class II
- MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Avanta Multi-Patient Disposable Hand Controller — Bayer Medical Care Inc. · Class II
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc. · Class II
- MEDRAD® Mark 7 Arterion Handswitch 6’ Standard — Bayer Medical Care Inc. · Class II
Cleared under the same submission
K790314 also covers:
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, INC.
- Medex — ICU MEDICAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 3a7556b0-bbe4-4523-ad48-5363c3fdd8c3 33 fields · synced May 30, 2026