Identity
- Trade Name
- Medex FDA UDI
- Generic Name
- Manual contrast medium injection system FDA UDI
- Model / Reference
- MX387 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688507921 FDA UDI
- 510(k) Number
- K883094 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Manual contrast medium injection system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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: Manual contrast medium injection system
Medex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual contrast medium injection system.
- LeverEdge Contrast Injector — LeMaitre Vascular, Inc. · Class II
- Palm Injector — APPLIED MEDICAL RESOURCES CORP. · Class II
- Medex — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K883094 also covers:
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 d9190ca9-5cdd-434f-8b8b-7b1e42cea7b2 33 fields · synced May 30, 2026