FDA.reportPublic FDA data

RHYTHMIA HDx™

Primary DI
08714729938651
Brand
RHYTHMIA HDx™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004RALRCBL20
Device description
Patch Cable
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729938651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729938651087147299386518714729938651

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

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
07613327666809N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.DSA2025-02-24
G096DR5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096GE5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096GE5VPS05009LineRising Eagle Medical LLCDSA2024-09-17
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G096PS5PS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5SS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5VPS05009LineRising Eagle Medical LLCDSA2024-09-17
G096PS5VSS05009LineRising Eagle Medical LLCDSA2024-09-17
G096MPS5PSC0500MEDALinkRising Eagle Medical LLCDSA2024-04-09
G096MGE3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MGE5PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MGE5VPS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MNK3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MNK6PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS3PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS5PS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MPS5VPS0500MEDALinkRising Eagle Medical LLCDSA2023-07-21
G096MA0001D030MEDALinkRising Eagle Medical LLCDSA2023-04-28
G096MA0001D060MEDALinkRising Eagle Medical LLCDSA2023-04-28
G096MA0002D050MEDALinkRising Eagle Medical LLCDSA2023-03-22
G096MA0002D050020MEDALinkRising Eagle Medical LLCDSA2023-03-22