Identity
- Trade Name
- INTELLAGEN™ Irrigation Pump Kit FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Model / Reference
- 20402 FDA UDI
Identifiers
- Catalog Number
- M004GEN100204020 FDA UDI
- Primary DI / UDI-DI
- 04260166374087 FDA UDI
- FDA Product Code
- OAD FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel 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
Yes
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
Category: Bedside infusion pump, single-channel
INTELLAGEN™ Irrigation Pump Kit by Stockert GmbH — Class III — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bedside infusion pump, single-channel.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
Sources (2)
- FDA UDI de3af5d9-7a16-4b5d-b7d6-daa14f7d9ef9 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026