FDA.reportPublic FDA data

INTEGRAL PROCESS Cables & Leadwires

Primary DI
03700506304813
Brand
INTEGRAL PROCESS Cables & Leadwires
Company
NISSHA MEDICAL TECHNOLOGIES SAS
Model
72466-US
Device description
ECG Trunk Cable - 5 Leads - MARQUETTE HELLIGE compatible - US Colour Code
Published
2023-02-23
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
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
K162768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162768000ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas2017-08-16DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700506304813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700506304813037005063048133700506304813

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33139726666FRorders@nisshamedical.com

Regulatory Flags#

DUNS number
391906658
Device count
1
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
03700506300853INTEGRAL PROCESS Cables & LeadwiresIPC710802026-07-24
03700506318940INTEGRAL PROCESS Cables & Leadwires72473-US2022-12-22
03700506319480INTEGRAL PROCESS Cables & Leadwires70612GEJ5T-US2022-12-22
03700506304653INTEGRAL PROCESS Cables & Leadwires72191-US2024-02-23
03700506319046INTEGRAL PROCESS Cables & Leadwires72191-US-3.50M2024-02-23
03700506319466INTEGRAL PROCESS Cables & Leadwires70612SJ5T-US2024-01-19
03700506320189INTEGRAL PROCESS Cables & Leadwires71041-US-5.5M2023-04-19
03700506320196INTEGRAL PROCESS Cables & Leadwires72350-US-5.5M2023-04-19
03700506303601INTEGRAL PROCESS Cables & Leadwires70611NGJ3-US2023-02-23
03700506303625INTEGRAL PROCESS Cables & Leadwires70611NGJ5-US2023-02-23
03700506303700INTEGRAL PROCESS Cables & Leadwires70612NGJ5-US2023-02-23
03700506303809INTEGRAL PROCESS Cables & Leadwires70618NGJ3-US2023-02-23
03700506304349INTEGRAL PROCESS Cables & Leadwires71780-US2023-02-23
03700506304790INTEGRAL PROCESS Cables & Leadwires72465-US2023-02-23
03700506311422INTEGRAL PROCESS Cables & Leadwires72465S-US2023-02-23
03700506312924INTEGRAL PROCESS Cables & Leadwires70610NGJ5-US2023-02-23
03700506318902INTEGRAL PROCESS Cables & Leadwires72712-US2023-02-23
03700506318919INTEGRAL PROCESS Cables & Leadwires72711-US2023-02-23
03700506319176INTEGRAL PROCESS Cables & Leadwires71780S-US2023-02-23
03700506319459INTEGRAL PROCESS Cables & Leadwires70612SJ5-US2023-02-23

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
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00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
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