Identity
- Trade Name
- MEDFUSION FDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Model / Reference
- 67-2391-010700-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019517155143 FDA UDI
- 510(k) Number
- K111386 FDA UDI
- FDA Product Code
- MRZ FDA UDIFRN FDA UDI
- GMDN Term
- Infusion pump medication-dosage application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
No
FDA UDI
Category: Infusion pump medication-dosage application software
Medfusion by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infusion pump medication-dosage application software.
- DOSE IQ SAFETY SOFTWARE — Baxter Healthcare Corp · Class II
- LifeShield Infusion Safety Software Suite — ICU MEDICAL FLEET SERVICES, LLC · Class II
- EndoTool IV — Monarch Medical Technologies, LLC · Class II
- Ivenix Infusion System — Fresenius Kabi · Class II
- DOSE IQ SAFETY SOFTWARE — Baxter Healthcare Corp · Class II
- EndoTool IV — Monarch Medical Technologies, LLC · Class II
- Ivenix Infusion System — Fresenius Kabi · Class II
- Alaris — CareFusion 303, INC · Class II
Cleared under the same submission
K111386 also covers:
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- MEDFUSION — ICU MEDICAL, INC.
- Medfusion — ICU MEDICAL, INC.
- Medfusion — ICU MEDICAL, INC.
- Medfusion — ICU MEDICAL, INC.
- Medfusion — ICU MEDICAL, INC.
- Medfusion — 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 30e6f4af-ac2d-4ef1-afb2-dc5ae747c891 33 fields · synced Jun 1, 2026