Identity
- Trade Name
- MEDSTREAM FDA UDI
- Generic Name
- General-purpose implantable infusion pump, programmable FDA UDI
- Device Name
- Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual FDA UDI
- Model / Reference
- 91-4201US FDA UDI
- Description
- Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual FDA UDI
Identifiers
- Catalog Number
- 91-4201US FDA UDI
- Primary DI / UDI-DI
- 10886704064930 FDA UDI
- PMA Number
- P890055 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- General-purpose implantable infusion pump, programmable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Medstream by Cerenovus, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 9c7f2604-17e8-4a13-9fd2-4c3e8e4ca7ec 38 fields · synced May 30, 2026