FDA.reportPublic FDA data

WEBSTER

Primary DI
10846835006971
Brand
WEBSTER
Company
BIOSENSE WEBSTER INC.
Model
F5ADP282CT
Catalog number
F5ADP282CT
Published
2016-09-16
Public version status
Update
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
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835006971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683500697110846835006971

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Do not use if package is opened
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep Dry | Keep out of direct sunlight
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
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
10846835018554VISITAG SURPOINT EPUM660202SPM660202SP2021-10-14
10846835018578VISITAG SURPOINT EPU SPAREM660201SPM660201SP2021-10-14
10846835018585VISITAG EXT PROCESSING UNIT ACCESSM665701SPM665701SP2021-10-14
10846835021110OCTARAY Mapping CatheterD160902D1609022021-10-14
10846835021127OCTARAY Mapping CatheterD160903D1609032021-10-14
10846835021134OCTARAY Mapping CatheterD160906D1609062021-10-14
10846835021141OCTARAY Mapping CatheterD160901D1609012021-10-14
10846835021158OCTARAY Mapping CatheterD160905D1609052021-10-14
10846835021233OCTARAY Mapping CatheterD160904D1609042021-10-14
10846835002379N/AADSTKADSTK2014-09-10
10846835002386N/AAESTKAESTK2014-09-10
10846835002393N/AAMSTKAMSTK2014-09-10
10846835002867EZ Steer ThermoCoolBDI75TCDDRTBDI75TCDDRT2014-09-10
10846835002874EZ Steer ThermoCoolBDI75TCDFRTBDI75TCDFRT2014-09-10
10846835002881EZ Steer ThermoCoolBDI75TCFFRTBDI75TCFFRT2014-09-10
10846835002898EZ Steer ThermoCoolBDI75TCFJRTBDI75TCFJRT2014-09-10
10846835002904EZ Steer ThermoCoolBDI75TCJJRTBDI75TCJJRT2014-09-10
10846835003314EZ Steer ThermoCool NAVBNI75TCDDHBNI75TCDDH2014-09-10
10846835003338EZ Steer ThermoCool NAVBNI75TCDFHBNI75TCDFH2014-09-10
10846835003352EZ Steer ThermoCool NAVBNI75TCFFHBNI75TCFFH2014-09-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
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24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
00763000719272NAMEDTRONIC, INC.DRF2024-08-22
00763000719289NAMEDTRONIC, INC.DRF2024-08-22
00763000719296NAMEDTRONIC, INC.DRF2024-08-22
00763000719302NAMEDTRONIC, INC.DRF2024-08-22
00763000443214NAMEDTRONIC, INC.DRF2024-05-18
00763000465728NAMEDTRONIC, INC.DRF2024-05-18
06952450918999EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919002EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919019EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942598EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942611EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942628EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942635EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952221EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952238EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952245EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952252EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952269EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952276EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952283EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952290EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952306EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952313EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952320EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21