Identity
- Trade Name
- Medex FDA UDI
- Generic Name
- Invasive-pressure external transducer, reusable FDA UDI
- Model / Reference
- MX5428R2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688506672 FDA UDI
- 510(k) Number
- K820355 FDA UDI
- FDA Product Code
- DRS FDA UDI
- GMDN Term
- Invasive-pressure external transducer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2850 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: Invasive-pressure external transducer, reusable
Medex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive-pressure external transducer, reusable.
- BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35 — PHYSIO-CONTROL, Inc. · Class II
- Invasive Pressure Adapter Cable, ICU — PHYSIO-CONTROL, Inc. · Class II
- BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- IBP Tansducer Kit Sensor 84 — Draeger Medical Systems, Inc. · Class II
- BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- SP 840 - 32021 — Memscap AS · Class II
- BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
Cleared under the same submission
K820355 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 |
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Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 914ba862-f603-4857-8ccd-14191ca6389c 33 fields · synced May 30, 2026