FDA.reportPublic FDA data

AMC

Primary DI
00849593017305
Brand
AMC
Company
Advantage Medical Electronics, LLC
Model
LW-329DS30/5A
Device description
5 Lead Disposable DIN to Pinch, Shld. 30"w/AMC Combiner
Published
2020-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
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
00849593017312PrimaryGS10
00849593017305Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593017312008495930173128495930173120849593017312
00849593017305008495930173058495930173050849593017305

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080242300
Device count
25
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849593008355AMCRPO-LW-329DS50/5A2026-02-16
10849593008362AMCRPO-LW-329DS120/5A2026-02-16
10849593025857AMCRPO-LW-329DS50/3A2026-02-16
10849593025888AMCRPO-LW-329DS30/5AT2026-02-16
10849593025901AMCRPO-LW-329DS120/5AT2026-02-16
10849593025925AMCRPO-LW-341DS30/5A2026-02-16
10849593025956AMCRPO-LW-381DS50/3A2026-02-16
10849593025963AMCRPO-LW-381DS50/6A2026-02-16
10849593025864AMCRPO-LW-329DS30/5A2026-01-13
10849593025895AMCRPO-LW-329DS50/5AT2026-01-07
10849593025918AMCRPO-LW-341DS50/3A2026-01-07
10849593025932AMCRPO-LW-341DS50/5A2026-01-07
10849593025949AMCRPO-LW-341DS50/5V2026-01-07
10849593025710AMCLWM-314DS29/5AS2025-05-05
10849593025499AMCLW-314DS29/5AS2024-10-24
00849593025355RochesterNC-8523752023-02-08
00849593025348RochesterNC-8526372023-02-08
00849593025379RochesterNC-8526502023-02-08
00849593025393RochesterNC-8527252023-02-08
00849593025416RochesterNC-8530252023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
04048675379300IBP Cable UtahDrägerwerk AG & Co. KGaADSA2026-01-07
04048675557722IBP Adapter Cable Dräger 7pinDrägerwerk AG & Co. KGaADSA2026-01-07
04048675379072IBP cable Becton DickinsonDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379089IBP Cable Abbott, MedexDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379096IBP cable EdwardsDrägerwerk AG & Co. KGaADSA2026-01-06
04048675557739IBP Adapter Cable Drager 10pinDrägerwerk AG & Co. KGaADSA2026-01-06
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08