Identity
- Trade Name
- Iradimed FDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Device Name
- MRIDIUM 3860 DERS LIBRARY KIT FDA UDI
- Model / Reference
- 1145 FDA UDI
- Description
- MRIDIUM 3860 DERS LIBRARY KIT FDA UDI
Identifiers
- Catalog Number
- 1145 FDA UDI
- Primary DI / UDI-DI
- 00856038001157 FDA UDI
- 510(k) Number
- K090087 FDA UDI
- FDA Product Code
- FRN 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
MR Conditional FDA UDI
Category: Infusion pump medication-dosage application software
Iradimed by Iradimed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infusion pump medication-dosage application software.
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- ICU Medical MedNet — ICU MEDICAL, INC. · Class II
- MEDFUSION — ICU MEDICAL, INC. · Class II
- EndoTool IV — Monarch Medical Technologies, LLC · Class II
- CADD — ICU MEDICAL, INC. · Class II
- CADD — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K090087 also covers:
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
- Iradimed — Iradimed Corporation
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
- Iradimed Corporation
Sources (1)
- FDA UDI 67beed67-8fce-419e-88d1-b23ff1c2f3f7 35 fields · synced Jun 8, 2026