Identity
- Trade Name
- Prometra Patient Therapy Controller FDA UDI
- Generic Name
- Infusion pump programmer FDA UDI
- Device Name
- The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device. FDA UDI
- Model / Reference
- 12860 FDA UDI
- Description
- The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810335020174 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 Patient Therapy Controller 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 Physician Configuration Device — 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 Physician Configuration Device — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flowonix Medical, Inc.
Sources (1)
- FDA UDI cb64da1a-48a4-49ed-876d-5d904c7e127c 35 fields · synced May 30, 2026