KDP72 Doppler Probe

Primary DI
05055679406146
Brand
KDP72 Doppler Probe
Company
DELTEX MEDICAL LIMITED
Model
9081-7002
Device description
A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the frequency of the reflected ultrasound waves caused by the moving blood cells are translated by the CardioQ™ into a real time display of the velocity of the blood against time. Analysis of the waveform provides information on a range of cardiac parameters to be derived.
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPTProbe, Blood-Flow, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142932000Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited2015-01-22DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5055679406122PackageGS15In Commercial Distribution
5055679406139PackageGS120In Commercial Distribution
5055679406153PackageGS119In Commercial Distribution
5055679406160PackageGS118In Commercial Distribution
05055679406146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5055679406122050556794061225055679406122
5055679406139050556794061395055679406139
5055679406153050556794061535055679406153
5055679406160050556794061605055679406160
05055679406146050556794061465055679406146

GMDN Terms#

Term, Definition table
TermDefinition
Transoesophageal vascular ultrasound probeA device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically constructed of flexible materials (e.g., polymers) and has a metal conducting core; it has multiple sensors at the distal end and a connector at the proximal end. It is typically used during general anaesthesia or in intensive care. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth40Centimeter
Length72Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
225232610
Device count
1
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
05055679404609HD-ICG Electrode Convenience Kits7057-70059057-70052019-02-22
05055679400076I2S6 Doppler Probe9090-70152016-09-07
05055679400083I2P24 Doppler Probe9090-70132016-09-07
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
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