FDA.reportPublic FDA data

INTELLAGEN™ Irrigation Pump Kit

Primary DI
04260166374087
Brand
INTELLAGEN™ Irrigation Pump Kit
Company
Stockert GmbH
Model
20402
Catalog number
M004GEN100204020
Published
2024-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260166374087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260166374087042601663740874260166374087

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Fragile, handle with care
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature22 Degrees Fahrenheit149 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-272-1001CETechSupportUSA@bsci.com

Regulatory Flags#

DUNS number
327536314
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260166374346INTELLAGEN™ Tubing Set20626206262024-09-01
04260166373066INTELLAGEN™ Foot Pedal20010M004GEN1002001002024-09-01
04260166373080INTELLAGEN™ Grounding Cable (3m)19943M004GEN1001994302024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)19947M004GEN1001994702024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)19949M004GEN1001994902024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)19948M004GEN1001994802024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)19944M004GEN1001994402024-09-01
04260166373134INTELLAGEN™ Irrigation Pump Connection Cable (5m)19946M004GEN1001994602024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)19951M004GEN1001995102024-09-01
04260166373165INTELLAGEN™ lntravenous (IV) Pole Clamp19945M004GEN1001994502024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)20072M004GEN1002007202024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)20075M004GEN1002007502024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)20078M004GEN1002007802024-09-01
04260166373240INTELLAGEN™ Irrigation Pump Connection Cable (1m)20081M004GEN1002008102024-09-01
04260166373257INTELLAGEN™ Irrigation Pump Connection Cable (3m)20084M004GEN1002008402024-09-01
04260166373264INTELLAGEN™ Irrigation Pump Connection Cable (10m)20087M004GEN1002008702024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)20090M004GEN1002009002024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)20094M004GEN1002009402024-09-01
04260166374063INTELLAGEN™ RF Generator20404M004GEN1002040102024-09-01
04260166374070INTELLAGEN™ RF Generator Kit20401M004GEN1002040102024-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
20763000995007N/AMEDTRONIC, INC.OAD2025-04-12
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAD2025-01-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAD2024-12-06
00763000871772NAMEDTRONIC, INC.OAD2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAD2024-11-04
20763000871776NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2024-11-04
00191506020798RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHOAD2024-09-01
04260166373080INTELLAGEN™ Grounding Cable (3m)Stockert GmbHOAD2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHOAD2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHOAD2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHOAD2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHOAD2024-09-01
04260166373134INTELLAGEN™ Irrigation Pump Connection Cable (5m)Stockert GmbHOAD2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHOAD2024-09-01