Identity
- Trade Name
- VOLUMAT MC AGILIA US FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Device Name
- The VOLUMAT MC AGILIA US is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals, according to hospital protocols on adults, paediatrics and neonates human patients to administer - intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration. - transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. FDA UDI
- Model / Reference
- Z021135 FDA UDI
- Description
- The VOLUMAT MC AGILIA US is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals, according to hospital protocols on adults, paediatrics and neonates human patients to administer - intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration. - transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. FDA UDI
Identifiers
- Catalog Number
- Z021135 FDA UDI
- Primary DI / UDI-DI
- 04086000851794 FDA UDI
- 510(k) Number
- K121613 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Bedside infusion pump, single-channel
Volumat Mc Agilia Us by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bedside infusion pump, single-channel.
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- Plum — Hospira, Inc. · Class II
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Cleared under the same submission
K121613 also covers:
- AGILIA USB CABLE US — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
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
- Fresenius Kabi
Sources (1)
- FDA UDI 29b5df1c-f6db-494c-848b-e2adb61bb34c 36 fields · synced Jun 1, 2026