← Back to catalogue
Penumbra System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref IAPS2Model Non-Sterile Pump MAX Supplies – Indigo System
Identity
- Trade Name
- Non-Sterile Pump MAX Supplies – Indigo System EUDAMEDPenumbra System FDA UDI
- Generic Name
- Surgical irrigation/aspiration system FDA UDI
- Device Name
- Pump MAX Canister EUDAMEDIndigo Pump Max Supplies FDA UDI
- Model / Reference
- IAPS2 EUDAMEDFDA UDINon-Sterile Pump MAX Supplies – Indigo System EUDAMED
- Description
- Indigo Pump Max Supplies FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810169721834 EUDAMED00814548013343 FDA UDI
- Basic UDI-DI
- 081454801INDSUP9R EUDAMED
- 510(k) Number
- K122756 FDA UDI
- FDA Product Code
- JCX FDA UDI
- EMDN Code
- A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
- GMDN Term
- Surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical irrigation/aspiration system
Penumbra System by Penumbra, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration system.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- ZOOM Aspiration Pump — Taiwan Biomaterial Co., Ltd. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- LMI IRRIGATION (STRAIGHT) CATHETER — LUCAS MEDICAL INC · Class II
- LMI IRRIGATION (STRAIGHT) CATHETER — LUCAS MEDICAL INC · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- ROCAFLOW Irrigation, Warming and Suction System — Promepla · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA UDI 7dac0823-0ffe-4a2b-ad1c-0f41823e84f3 34 fields · synced Jun 18, 2026
- EUDAMED 58e75ba9-1996-41c2-b589-2ad1d59a76e0 61 fields · synced Jun 18, 2026