FDA.reportPublic FDA data

Deltex Medical CardioQ EDM

Primary DI
05055679404319
Brand
Deltex Medical CardioQ EDM
Company
DELTEX MEDICAL LIMITED
Model
9051-7057
Device description
The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with real-time information about left-ventricular blood flow.
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111542000DELTEX MEDICAL CARDIOQ EDMDeltex Medical Limited2011-10-20DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5055679406108PackageGS11In Commercial Distribution
05055679404319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5055679406108050556794061085055679406108
05055679404319050556794043195055679404319

GMDN Terms#

Term, Definition table
TermDefinition
Transoesophageal vascular ultrasound monitorA mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It is based on measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle) and is displayed on the monitor as a velocity/time waveform. It is typically used during a surgical procedure or in intensive care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
05055679404623HD-ICG Electrode Convenience Kits7057-70057057-70052019-02-22
5055679401547I2S6 Doppler Probe9090-70152016-09-07
5055679401745I2P24 Doppler Probe9090-70132016-09-07
05055679404326Deltex Medical CardioQ EDM+9051-71662016-09-07
5055679406122KDP72 Doppler Probe9081-70022016-09-07

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