FDA.reportPublic FDA data

Sensoronics

Primary DI
00851456007569
Brand
Sensoronics
Company
SENSORONICS INCORPORATED
Model
SECG-PHP3L-1603
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K120010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120010000CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)Shenzhen Med-Link Electronics Tech Co., Ltd.2012-01-19DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851456007569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851456007569008514560075698514560075690851456007569

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079579147
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851456007538SensoronicsSECG-GE12L-TC 2016-09-26
00851456007545SensoronicsSECG-GE5L-E512016-09-26
00851456007552SensoronicsSECG-GE5L-W512016-09-26
00851456007576SensoronicsSECG-PHP3L-16052016-09-26
00851456007583SensoronicsSECG-PHP3L-16712016-09-26
00851456007590SensoronicsSECG-PHP3L-1673 2016-09-26
00851456007606SensoronicsSECG-PHP3L-TC15002016-09-26
00851456007613SensoronicsSECG-PHP3L-TC1580 2016-09-26
00851456007620SensoronicsSECG-PHP3L-TC1669 2016-09-26
00851456007637SensoronicsSECG-PHP5L-1623 2016-09-26
00851456007644SensoronicsSECG-PHP5L-16252016-09-26
00851456007651SensoronicsSECG-PHP5L-16442016-09-26
00851456007668SensoronicsSECG-PHP5L-1968 2016-09-26
00851456007675SensoronicsSECG-PHP5L-TC1520 2016-09-26
00851456007682SensoronicsSECG-PHP5L-TC16002016-09-26
00851456007699SensoronicsSECG-PHP5L-TC1668 2016-09-26
00851456007705SensoronicsSECG-PHY12L-TC5 2016-09-26
00851456007712SensoronicsSECG-PHY12L-TC8 2016-09-26
00851456007729SensoronicsSECG-PHY6L-3 2016-09-26
00851457007278SesoronicsSPO5002019-09-27

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