Identity
- Trade Name
- Prometra Refill Kit FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill the Prometra Programmable Pump. The drug chamber is refillable and is percutaneously accessed via the centrally-located access port using a 22-gauge non-coring needle. FDA UDI
- Model / Reference
- 11825 FDA UDI
- Description
- The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill the Prometra Programmable Pump. The drug chamber is refillable and is percutaneously accessed via the centrally-located access port using a 22-gauge non-coring needle. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810335020143 FDA UDI
- PMA Number
- P080012 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General surgical procedure kit, non-medicated, single-use
Prometra Refill Kit by Flowonix Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General surgical procedure kit, non-medicated, single-use.
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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 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.
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 e28ab7f7-159e-4016-920a-c697ed539d0c 34 fields · synced Jun 1, 2026