FDA.reportPublic FDA data

NeoLead RadioLucent

Primary DI
00812594010293
Brand
NeoLead RadioLucent
Company
Neotech Products LLC
Model
812594010293
Catalog number
N305B
Device description
Electrode (Each)
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00812594010293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812594010293008125940102938125940102930812594010293

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
198013435
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812594010177NeoBridge®MicoN7002021-05-19
10812594010269NeoBridge®SmallN7012021-05-19
10812594010276NeoBridge®LargeN7022021-05-19
10812594010351EZ-Hold®StandardN7572021-05-19
10812594010726NeoGrip®BlueN602B2021-05-19
10812594010740NeoGrip®Pink & BlueN6022021-05-19
10812594010764NeoGrip®VersaGrip - LargeN6012021-05-19
10812594010788NeoGrip®WhiteN6032021-05-19
10812594011037Hold-A-Line™StandardN7052021-06-02
10812594011358EZ-Hold®MiniN7562021-05-19
10812594011952Telemetry TotesClip-ToteA5012021-06-14
10812594011969Telemetry TotesValu-ToteA5072021-06-14
10812594012096EZ-Hold®Extra LargeN7582021-05-19
10812594012102NeoGrip®RedN602R2021-05-19
10812594012119NeoGrip®Neon GreenN602G2021-05-19
10812594012126NeoGrip®YellowN602Y2021-05-19
10812594012133NeoGrip®OrangeN602O2021-05-19
10812594012140NeoGrip®VioletN602V2021-05-19
10812594012461NeoGrip®PinkN602P2021-05-19
20812594012925NeoSnug Small20812594012925N7015-152023-09-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20