FDA.reportPublic FDA data

Sensoronics

Primary DI
00851456007699
Brand
Sensoronics
Company
SENSORONICS INCORPORATED
Model
SECG-PHP5L-TC1668
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
00851456007699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851456007699008514560076998514560076990851456007699

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
00851456007569SensoronicsSECG-PHP3L-1603 2016-09-26
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
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
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