FDA.reportPublic FDA data

Nissha Medical Technologies

Primary DI
30009336010593
Brand
Nissha Medical Technologies
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
O-4227-60
Catalog number
4010453C
Device description
Vermed SimplySnap Offset Electrodes
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30009336010593PackageGS11200In Commercial Distribution
50009336010597PackageGS17200In Commercial Distribution
10009336010599PrimaryGS10
00009336010592Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3000933601059330009336010593
5000933601059750009336010597
1000933601059910009336010599
00009336010592000093360105920093360105920009336010592

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
Special Storage Condition, Specify00Keep dry, Protect from light

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002111896
Device count
60
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
30009336010630Nissha Medical TechnologiesUltra 210HD Thermal Video Paper320190642026-06-01
00009336008216Vermed20100-125-SNAP20100-125-SNAP2017-02-28
00009336008223Vermed20300-18-RED20300-18-RED2017-02-28
00009336008230Vermed20300-18-WHT20300-18-WHT2017-02-28
00009336008247Vermed20900-18-3A20900-18-3A2017-02-28
00009336008254Vermed20900-24-3A20900-24-3A2018-09-28
00009336008261Vermed20900-53-GRN20900-53-GRN2017-02-28
00009336008278Vermed20900-96-RED20900-96-RED2017-02-28
00009336008315Vermed41656416562017-02-28
00009336008322Vermed20900-18-RED20900-18-RED2017-02-28
00009336008339Vermed20900-48-WHT20900-48-WHT2017-02-28
10009336010322Zoll PL Defib8900-004041-017000018322023-10-30
10813150020227PerformancePlus™A10005A100052016-09-16
50813150020911NeuroPlus™A10041-5A10041-52017-04-07
00813150020107PerformancePlus™A10005-4NBA10005-4NB2016-09-16
00813150020121PerformancePlus™A10005-60A10005-602016-09-16
00813150020183PerformancePlus™A10005-7NBA10005-7NB2016-09-16
20813150020941NeuroPlus™A10042-10A10042-102017-04-07
20813150020972NeuroPlus™A10043A100432017-04-07
40813150020860NeuroPlus™A10040-5A10041-02017-04-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
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
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08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283017Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283024Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283048Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20