Identity
- Trade Name
- AGILIA USB CABLE US FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software. FDA UDI
- Model / Reference
- Z073550 FDA UDI
- Description
- The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software. FDA UDI
Identifiers
- Catalog Number
- Z073550 FDA UDI
- Primary DI / UDI-DI
- 04086000852074 FDA UDI
- 510(k) Number
- K121613 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
No
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
Category: Electrical-only medical device connection cable, reusable
Agilia Usb Cable Us by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121613 also covers:
- Secondary Line — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- VOLUMAT MC AGILIA US — 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 9195e981-e903-48aa-9849-8c56156ae5d2 35 fields · synced May 30, 2026