FDA.reportPublic FDA data

CLARAVUE

Primary DI
13700506300171
Brand
CLARAVUE
Company
NISSHA MEDICAL TECHNOLOGIES SAS
Model
50604-US
Device description
CLARAVUE PM 5 RT US
Published
2023-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101685000IP-SETIntegral Process Sas2010-07-01DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700506300171PackageGS130In Commercial Distribution
23700506300178PackageGS1360In Commercial Distribution
03700506300174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1370050630017113700506300171
2370050630017823700506300178
03700506300174037005063001743700506300174

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
391906658
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700506301775INTEGRAL PROCESS Cables & LeadwiresIPC724672026-08-27
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
03700506304813INTEGRAL PROCESS Cables & Leadwires72466-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281587Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20