FDA.reportPublic FDA data

SonoTT Vascular Probe

Primary DI
04062114000129
Brand
SonoTT Vascular Probe
Company
em-tec GmbH
Model
11344
Catalog number
11344
Device description
High quality workmanship Ultrasonic Flow Probes for the measurement ofblood flow in vessels and grafts. The probes are showing excellent accuracyand stability. Calibration data are stored in the probe.The probes can be manually and automatically cleaned and disinfected andsterilized with steam, ethylene oxide (EtO), low temperature steam and form -aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We supportup to 50 sterilisation cycles
Published
2018-09-20
Public version status
New
Distribution status
Not 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
K111730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111730000SONOTT FLOWLAB(R)Em-Tec GmbH2012-01-06DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04062114000129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04062114000129040621140001294062114000129

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+49880692360info@em-tec.de

Regulatory Flags#

DUNS number
320025190
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04062114000013SonoTT FlowLab11916119162018-09-20
04062114000037Clamp-On Transducer11783117832018-09-20
04062114000044Clamp-On Transducer11767117672018-09-20
04062114000051Clamp-On Transducer11768117682018-09-20
04062114000068Clamp-On Transducer11782117822018-09-20
04062114000075Clamp-On Transducer12131121312018-09-20
04062114000082Clamp-On Transducer12133121332018-09-20
04062114000099Clamp-On Transducer12132121322018-09-20
04062114000105SonoTT Vascular Probe11342113422018-09-20
04062114000112SonoTT Vascular Probe11343113432018-09-20
04062114000136SonoTT Vascular Probe11345113452018-09-20
04062114000143SonoTT Vascular Probe11939119392018-09-20
04062114000150SonoTT Vascular Probe11940119402018-09-20
04062114000167SonoTT Vascular Probe11346113462018-09-20
04062114000174SonoTT Vascular Probe11347113472018-09-20
04062114000181SonoTT Vascular Probe11348113482018-09-20
04062114000198SonoTT Vascular Probe11349113492018-09-20
04062114000204SonoTT Vascular Probe11941119412018-09-20
04062114000211SonoTT Vascular Probe11942119422018-09-20
04062114000266Sono TT Ultrasonic Flowcomputer11923119232018-09-20

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