FDA.reportPublic FDA data

HD-ICG Electrode Convenience Kits

Primary DI
05055679404609
Brand
HD-ICG Electrode Convenience Kits
Company
DELTEX MEDICAL LIMITED
Model
7057-7005
Catalog number
9057-7005
Device description
The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization of hemodynamic performance in anesthetized, sedated or conscious patients; and is intended for use in the operating room, intensive care unit, emergency room, obstetrics department or other wards or departments where hemodynamic measurement is required. HD-ICG Electrode Convenience Kits contains 2 packs of 3 electrodes and a RFID smart card in a labelled clear plastic bag. The Kits are sold in a labelled shelf box which contains 5 Convenience kits.
Published
2019-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05055679404616PackageGS15In Commercial Distribution
05055679404623PackageGS120In Commercial Distribution
05055679404609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055679404616050556794046165055679404616
05055679404623050556794046235055679404623
05055679404609050556794046095055679404609

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 Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8645275913ussales@deltexmedical.com
+4401243774837customer.services@deltexmedical.com

Regulatory Flags#

DUNS number
225232610
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055679400038DP240 Doppler Probe9070-70059070-70062016-09-07
05055679400076I2S6 Doppler Probe9090-70152016-09-07
05055679400083I2P24 Doppler Probe9090-70132016-09-07
05055679406146KDP72 Doppler Probe9081-70022016-09-07
05055679400090I2C72 Doppler Probe9090-70172016-09-07
5055679400748DP240 Doppler Probe9070-70052016-09-07
05055679404623HD-ICG Electrode Convenience Kits7057-70057057-70052019-02-22
5055679401547I2S6 Doppler Probe9090-70152016-09-07
5055679401745I2P24 Doppler Probe9090-70132016-09-07
05055679404319Deltex Medical CardioQ EDM9051-70572016-09-07
05055679404326Deltex Medical CardioQ EDM+9051-71662016-09-07
5055679406122KDP72 Doppler Probe9081-70022016-09-07

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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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