I2P24 Doppler Probe

Primary DI
5055679401745
Brand
I2P24 Doppler Probe
Company
DELTEX MEDICAL LIMITED
Model
9090-7013
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 refl
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K073593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073593000I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016Deltex Medical Limited2009-01-29DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5055679401745PackageGS15In Commercial Distribution
5055679401912PackageGS118In Commercial Distribution
5055679401929PackageGS119In Commercial Distribution
5055679401936PackageGS120In Commercial Distribution
05055679400083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5055679401745050556794017455055679401745
5055679401912050556794019125055679401912
5055679401929050556794019295055679401929
5055679401936050556794019365055679401936
05055679400083050556794000835055679400083

GMDN Terms#

Term, Definition table
TermDefinition
Transoesophageal vascular ultrasound probeA sterile 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
Depth50Centimeter
Length89Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
05055679404623HD-ICG Electrode Convenience Kits7057-70057057-70052019-02-22
5055679401547I2S6 Doppler Probe9090-70152016-09-07
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
00763000419899Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
00763000419905Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
20763000419893Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
20763000419909Bio-Probe™MEDTRONIC, INC.DPT2021-09-18
15060484490157moorFLPI-2 Clinical PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2018-12-13
00643169630635Bio-Probe™MEDTRONIC, INC.DPT2017-01-22
00643169630642Bio-Probe™MEDTRONIC, INC.DPT2017-01-21
10351688507990MedexICU MEDICAL, INC.DPT2016-12-30
10351688508669MedexICU MEDICAL, INC.DPT2016-12-30
10351688516916MedexICU MEDICAL, INC.DPT2016-12-30
50351688508667MedexICU MEDICAL, INC.DPT2016-12-30
50351688516914MedexICU MEDICAL, INC.DPT2016-12-30
10351688503060MedexICU MEDICAL, INC.DPT2016-12-29
10351688505187MedexICU MEDICAL, INC.DPT2016-12-29
10351688505743MedexICU MEDICAL, INC.DPT2016-12-29
50351688505741MedexICU MEDICAL, INC.DPT2016-12-29
10351688503008MedexICU MEDICAL, INC.DPT2016-12-13
50351688503006MedexICU MEDICAL, INC.DPT2016-12-13
10351688503619MedexICU MEDICAL, INC.DPT2016-12-07
10351688503671MedexICU MEDICAL, INC.DPT2016-12-07
10351688503718MedexICU MEDICAL, INC.DPT2016-12-07
10351688503794MedexICU MEDICAL, INC.DPT2016-12-07
50351688503792MedexICU MEDICAL, INC.DPT2016-12-07
15060484490119moorFLPI-2 Review PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
15060484490126moorFLPI2- Measurement PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
10351688508416MedexICU MEDICAL, INC.DPT2016-10-19
10351688508423MedexICU MEDICAL, INC.DPT2016-10-19
10351688508560MedexICU MEDICAL, INC.DPT2016-10-19
10351688508775MedexICU MEDICAL, INC.DPT2016-10-19
10351688508782MedexICU MEDICAL, INC.DPT2016-10-19