FDA UDI
In Commercial Distribution
🇺🇸 United States
INTELLAGEN™ Irrigation Pump
DI: 04260166374117
·
Model: 20405
·
Stockert GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTELLAGEN™ Irrigation Pump
- Primary DI
- 04260166374117
- Version / Model
- 20405
- Catalog Number
- M004GEN100204020
- Company Name
- Stockert GmbH
- Labeler DUNS
- 327536314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-01
- Public Version
- 2
- Public Version Date
- 2026-01-19
- Public Version Status
- Update
- Public Device Record Key
- 3f632d1c-c0a4-47fa-b10f-d3ae29d74389
Device Description
Only commercialized as part of the kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | Unknown | 3 | |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13215 | Bedside infusion pump, single-channel | An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260166374117 | GS1 |
Customer Contacts
- Phone
- +1-888-272-1001
- [email protected]