FDA.reportPublic FDA data

AMC

Primary DI
00849593025836
Brand
AMC
Company
LifeSync Corporation
Model
LW-3410051/4V
Device description
4 Lead Reusable GE CS1 to Pinch, Shield, 51”, V-Leads
Published
2025-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992524000PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRESAdvantage Medical Electronics, Inc.2000-03-01DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593025836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593025836008495930258368495930258360849593025836

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
954-345-9800info@advantagemed.com

Regulatory Flags#

DUNS number
360791383
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849593000000AMCAC-6X924/CCL 2019-07-29
00849593005340LifeSyncLS-238B2022-11-21
00849593005760LifeSyncLS-2292022-11-20
00849593005807LifeSyncLS-229D2022-11-20
00849593008358AMCRPO-LW-329DS50/5A2026-02-16
00849593008365AMCRPO-LW-329DS120/5A2026-02-16
00849593009720UltraPointNM-0163882018-11-20
00849593009966RochesterNS-S86015-T1-10SC2018-11-20
00849593015547RochesterSE-222466-502018-11-20
00849593017312AMCLW-329DS30/5A2020-06-10
00849593017350AMCLW-329DS120/5A2020-06-24
00849593017374AMCLWM-329DS120/5A2020-06-10
00849593017398AMCLW-329DS120/5AT2020-06-10
00849593017411AMCLWM-329DS120/5AT2020-06-10
00849593017435AMCLWM-318DS50/5DR2020-06-23
00849593017619AMCLWM-229DS50/3A2020-07-09
00849593017633AMCLWM-229DS50/5A2020-07-09
00849593017657AMCLWM-229DS50/6A2020-07-09
00849593017671AMCLWM-329DS50/6A2020-07-09
00849593017695AMCLWM-229DS50/5AT2020-07-09

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
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19