FDA.reportPublic FDA data

INTELLAGEN™ Tubing Set 10 PK

Primary DI
04260166374353
Brand
INTELLAGEN™ Tubing Set 10 PK
Company
Stockert GmbH
Model
20625
Catalog number
M004GEN100206251
Published
2024-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
04260166374353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260166374353042601663743534260166374353

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ablation system irrigation tubing setA collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit86 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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