FDA.reportPublic FDA data

Z-Brand™

Primary DI
20813150020385
Brand
Z-Brand™
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
Z35RT-3
Catalog number
6502724V
Published
2019-11-18
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

Contact Domains#

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
20813150020385PackageGS11200In Commercial Distribution
10813150020388PrimaryGS10
00813150020381Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081315002038520813150020385
1081315002038810813150020388
00813150020381008131500203818131500203810813150020381

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 Temperature10 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.669.6905info@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
3
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
30009336010593Nissha Medical TechnologiesO-4227-604010453C2026-02-26
30009336010609Nissha Medical TechnologiesO-5235-604010425C2026-02-26
03700506307067BardBardIPC730412019-08-30
03700506307081BiosenseCARTO3IPC730802019-08-30
03700506307098Physio ControlLifepackIPC735112019-08-30
03700506307104St Jude MedicalSt Jude MedicalIPC737452019-08-30
00009336010332SilverRest Resting ECG TAB ElectrodeA100246500045V2024-11-14
00009336002559VermedLWG-6090029/3ALWG-6090029/3A2016-09-24
00009336002573VermedLWG-3090029/3ALWG-3090029/3A2016-09-24
00009336002597VermedLWG-3090029/5ALWG-3090029/5A2017-05-02
00009336002603VermedLWG-2090029GR LWG-2090029GR 2016-09-24
00009336002610VermedLWG-2090029RDLWG-2090029RD2016-09-24
00009336002627VermedLWG-2090029WH LWG-2090029WH 2016-09-24
00009336002665VermedLWG-2090029/3A LWG-2090029/3A 2016-09-24
00009336002672VermedLWG-2090029/5ALWG-2090029/5A2016-09-24
00009336002689VermedLWG-2090029BK LWG-2090029BK 2016-09-24
00009336002696VermedLWG-2090029BR LWG-2090029BR 2016-09-24
00009336002795VermedLWG-3300051/5ALWG-3300051/5A2016-09-24
00009336002863VermedLWG-3300029/5ALWG-3300029/5A2016-09-24
00009336002870VermedLWG-3300029/5AT LWG-3300029/5AT 2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009331808EXG Radiolucent Electrode System 12-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
10860009331812EXG Radiolucent Electrode System 3-Lead Posterior ElectrodeCB Innovations, LLCDRX2026-03-09
10860009331898EXG Radiolucent Electrode System 4-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
00860009331853EXG Radiolucent Electrode 5-Lead Cardiac Rhythm ElectrodeCB Innovations, LLCDRX2026-03-05
30009336010593Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
30009336010609Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
08033315120394BIONENBIONEN SAS DI BARBARA NENCIONI & C.DRX2026-02-16
06946725512708APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512715APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512722APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512739APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512746APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512753APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512760APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512777APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512784APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512791APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512807APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512814APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512821APKAPK Technology Co.,Ltd.DRX2026-01-23
00853512006998NIKOTRACENIKOMED USADRX2026-01-23
06946725512685APKAPK Technology Co.,Ltd.DRX2026-01-20
06946725512692APKAPK Technology Co.,Ltd.DRX2026-01-20
29005531002764SkintactLeonhard Lang GmbHDRX2026-01-15
29005531003044SkintactLeonhard Lang GmbHDRX2026-01-14
04719872981640QT ECGQt Medical, Inc.DRX2025-12-30
06946725512364APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512371APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512388APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512395APKAPK Technology Co.,Ltd.DRX2025-12-25