FDA.reportPublic FDA data

Klear-Trace

Primary DI
00813880023119
Brand
Klear-Trace
Company
TRINITY MEDICAL DEVICES INC.
Model
4810
Device description
Long Term Infant/Pediatric Electrodes
Published
2018-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861364000NEOGUARD ECG ELECTRODESCas Medical Systems, Inc.1986-08-06DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813880023119PrimaryGS10
00813880023232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813880023119008138800231198138800231190813880023119
00813880023232008138800232328138800232320813880023232

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal electrocardiographic electrodeA non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078728314
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813880027551Trinity Medical DevicesTET150S2024-04-24
00813880027568Trinity Medical DevicesTET170S2024-04-24
00813880027575Trinity Medical DevicesTET230S2024-04-24
00813880027520Trinity Medical DevicesTET150S2024-04-24
00813880027537Trinity Medical DevicesTET170S2024-04-24
00813880027544Trinity Medical DevicesTET230S2024-04-24
00813880027032Trinity Medical DevicesTST600C2023-08-07
00813880027322Trinity Medical DevicesTST600CF008138800273152023-08-07
00813880027513Klear-TracePN022023-08-07
00813880026967Trinity Medical DevicesTST600C2023-08-07
00813880027490Klear-TracePN022023-08-07
00813880022174Klear-Trace20002018-10-15
00813880023102Klear-Trace48002018-10-15
00813880025496Trinity Medical DevicesTST6002023-05-31
00813880025502Trinity Medical DevicesTST6002023-05-31
10813880020009Trinity Medical DevicesTAW1402023-02-11
10813880020016Trinity Medical DevicesTAW1502023-02-11
10813880020023Trinity Medical DevicesTAW1602023-02-11
10813880020030Trinity Medical DevicesTAW1702023-02-11
10813880020047Trinity Medical DevicesTAW1802023-02-11

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Primary DI, Brand, Company table
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09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
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10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14