FDA.reportPublic FDA data

Trulink

Primary DI
10841522103339
Brand
Trulink
Company
Statcorp Medical
Model
Patient cables & ECG leadwires
Catalog number
306655-003
Device description
PKGD CABLE,CARDIAC OUTPU T,EDWARDS,ROHS
Published
2017-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSIDETECTOR AND ALARM, ARRHYTHMIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103142000SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.2011-03-03DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522103339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210333910841522103339

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
602075905
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
10841522112126SoftcheckSoftCheck BP Cuffs3009167-0302016-12-01
10841522112188SoftcheckSoftCheck BP Cuffs3009167-0342016-12-01
10841522109577UltracheckUltraCheck BP CuffsUS1826MB2016-10-24
10841522109638UltracheckUltraCheck BP CuffsUS3544MB2016-10-24
10841522109898UltracheckUltraCheck BP CuffsUD1826MQ2016-10-19
10841522110009UltracheckUltraCheck BP CuffsUD2938MQ2016-10-19
10841522110061UltracheckUltraCheck BP CuffsUD3242MQ2016-10-19
10841522106576Statcorp MedicalSTATCORPUD0814MQMF2016-10-04
10841522107665UltracheckUltraCheck BP CuffsUS4250DM2016-10-04
10841522108228SoftcheckSoftCheck BP CuffsNN4DT2016-11-10
10841522108310SoftcheckSoftCheck BP CuffsVDT3544DM2016-10-24
10841522109119SoftcheckSoftCheck BP CuffsST1826DM2016-10-04
10841522109225SoftcheckSoftCheck BP CuffsST2635DM2016-10-04
10841522109270UltracheckUltraCheck BP CuffsUS1320MML2016-10-24
10841522109263SoftcheckSoftCheck BP CuffsST2635ML2016-12-07
10841522109133UltracheckUltraCheck BP CuffsN/A2016-12-15
10841522130458TrulinkABP Cuffs and Cuff Covers715-3021-002025-03-13
10841522130465TrulinkABP Cuffs and Cuff Covers715-3022-002025-03-13
10841522130472TrulinkABP Cuffs and Cuff Covers715-3031-002025-03-13
10841522130489TrulinkABP Cuffs and Cuff Covers715-3032-002025-03-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838119130Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119233Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-03-09
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838128729C6 Monitor A13, VerizonBRAEMAR MANUFACTURING, LLCDSI2025-10-06
00884838128736C6 Monitor A13, T MobileBRAEMAR MANUFACTURING, LLCDSI2025-10-06
06944413838406Patient Monitor Edan Instruments, Inc.DSI2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.DSI2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgDSI2024-11-27
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