FDA.reportPublic FDA data

HD-ICG Electrode Convenience Kits

Primary DI
05055679404623
Brand
HD-ICG Electrode Convenience Kits
Company
DELTEX MEDICAL LIMITED
Model
7057-7005
Catalog number
7057-7005
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 perform
Published
2019-02-22
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
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
225232610
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055679400038DP240 Doppler Probe9070-70059070-70062016-09-07
05055679404609HD-ICG Electrode Convenience Kits7057-70059057-70052019-02-22
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
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

Other Devices Sharing Product Codes#

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
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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