FDA.reportPublic FDA data

Cool Point™

Primary DI
05415067016669
Brand
Cool Point™
Company
IRVINE BIOMEDICAL, INC.
Model
H701666
Catalog number
H701666
Device description
Irrigation Pump Pressure Alarm Adapter Cable
Published
2024-01-12
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
P060019029

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060019029IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFIrvine Biomedical, Inc.2007-03-16OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067016669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067016669054150670166695415067016669

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

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
05414734308830NAIBI-85710IBI-857102014-10-31
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