Identity
- Trade Name
- Prometra Physician Configuration Device FDA UDI
- Generic Name
- Infusion pump programmer FDA UDI
- Device Name
- The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller. FDA UDI
- Model / Reference
- 12861 FDA UDI
- Description
- The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810335020181 FDA UDI
- PMA Number
- P080012 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- Infusion pump programmer FDA UDI
Classification
- Device Class
- Class III 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: Infusion pump programmer
Prometra Physician Configuration Device by Flowonix Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infusion pump programmer.
- Prometra Patient Therapy Controller — Flowonix Medical, Inc. · Class III
- Prometra Programmer — Flowonix Medical, Inc. · Class III
- Prometra Clinical Programmer — Flowonix Medical, Inc. · Class III
- Prometra Clinician Programmer Print Tool — Flowonix Medical, Inc. · Class III
- Prometra Programmer — Flowonix Medical, Inc. · Class III
Cleared under the same submission
P080012 also covers:
- Prometra Catheter Access Kit — Flowonix Medical, Inc.
- Prometra Catheter Revision Kit — Flowonix Medical, Inc.
- Prometra Clinical Programmer — Flowonix Medical, Inc.
- Prometra Clinician Programmer Print Tool — Flowonix Medical, Inc.
- Prometra II Pump — Flowonix Medical, Inc.
- Prometra Intrathecal Catheter — Flowonix Medical, Inc.
- Prometra Patient Therapy Controller — Flowonix Medical, Inc.
- Prometra Programmable Pump — Flowonix Medical, Inc.
- Prometra Programmable Pump — Flowonix Medical, Inc.
- Prometra Programmer — Flowonix Medical, Inc.
- Prometra Programmer — Flowonix Medical, Inc.
- Prometra Refill Kit — Flowonix 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 III | Pending data |
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Manufacturer
- Manufacturer
- Flowonix Medical, Inc.
Sources (1)
- FDA UDI d7705fdc-5d2f-43df-8f61-9382c23d83cd 35 fields · synced Jun 1, 2026