FDA.reportPublic FDA data

NA

Primary DI
05414734308830
Brand
NA
Company
IRVINE BIOMEDICAL, INC.
Model
IBI-85710
Catalog number
IBI-85710
Device description
Grounding Cable 1710
Published
2014-10-31
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
LPBCardiac ablation percutaneous catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040014000IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORIrvine Biomedical, Inc.2005-01-14LPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734308830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734308830054147343088305414734308830

GMDN Terms#

Term, Definition table
TermDefinition
Electrical catheter connection cable, reusableAn insulated electrical conductor designed to provide an electrical connection between an electrical catheter (e.g., an electrophysiological diagnostic catheter or ablation catheter) and an electrically-powered parent device (e.g., generator, analyser). Its length may also allow the catheter to remain in the sterile field. This device will be made of robust materials with metal connectors, e.g., gold (Au) plated electrical connecting pins and sockets, that ensure continued reliability each time it is reused. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.
Special Storage Condition, Specify00Keep in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
926346966
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734303415Inquiry™IBI-81199IBI-811992016-03-18
05414734303538Inquiry™IBI-81213IBI-812132015-02-10
05414734303613Inquiry™IBI-81221IBI-812212015-02-10
05414734309257NAIBI-85942IBI-859422025-12-09
05415067053190ViewFlex™ICE-VF-SE-2D-01ICE-VF-SE-2D-012025-11-21
05415067002082ViewFlex™D087031D0870312016-01-12
05415067016669Cool Point™H701666H7016662024-01-12
05414734309080NAIBI-85786IBI-857862014-10-31
05415067008985Cool Point™IBI-89003IBI-890032014-09-29
05414734258616Cool Point™85785857852014-09-29
05414734302975Inquiry™IBI-81104IBI-811042015-02-10
05414734303132Inquiry™IBI-81120IBI-811202015-03-10
05414734303149Inquiry™IBI-81121IBI-811212015-03-10
05414734303163Inquiry™IBI-81124IBI-811242015-03-10
05414734303170Inquiry™IBI-81125IBI-811252015-05-22
05414734303187Inquiry™IBI-81126IBI-811262015-05-22
05414734303217Inquiry™IBI-81130IBI-811302015-03-10
05414734303248Inquiry™IBI-81134IBI-811342015-03-10
05414734303309Inquiry™IBI-81144IBI-811442015-03-10
05414734303477Inquiry™IBI-81207IBI-812072015-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
04044508136959MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137031iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONLPB2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHLPB2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHLPB2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHLPB2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHLPB2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHLPB2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHLPB2024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)Stockert GmbHLPB2024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)Stockert GmbHLPB2024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)Stockert GmbHLPB2024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)Stockert GmbHLPB2024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)Stockert GmbHLPB2024-09-01
04260166374063INTELLAGEN™ RF GeneratorStockert GmbHLPB2024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbHLPB2024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbHLPB2024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbHLPB2024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbHLPB2024-09-01
00763000719265NAMEDTRONIC, INC.LPB2024-08-22
00763000719319NAMEDTRONIC, INC.LPB2024-08-22
00763000593889NAMEDTRONIC, INC.LPB2024-02-17