FDA.reportPublic FDA data

Smartdop 45

Primary DI
00894912002135
Brand
Smartdop 45
Company
KOVEN TECHNOLOGY, INC.
Model
Smartdop 45
Catalog number
Smartdop 45
Device description
Bidirectional recording vascular Doppler.
Published
2016-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050601000SMARTDOP 45 VASCULAR DOPPLERKoven Technology, Inc.2005-04-15DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894912002135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894912002135008949120021358949120021350894912002135

GMDN Terms#

Term, Definition table
TermDefinition
Vascular ultrasound system control unitA mains electricity (AC-powered) external device, which may include internal rechargeable batteries, intended to be used to indicate (visually and/or sonically) blood flow in a peripheral blood vessel, through connection to a dedicated probe/catheter (not included), using ultrasound/Doppler/transit time technology. It may be intended to locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) or to monitor blood flow in association with microvascular surgery.

Contacts#

Phone, Email table
PhoneEmail
314-542-2101info@koven.com

Regulatory Flags#

DUNS number
069261402
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894912002173ES102EXES102EXES102EX2016-02-24
00894912002180DVM 4500DVM 4500DVM 45002016-03-10
00894912002302BT10M5S8ABT10M5S8ABT10M5S8A2016-03-10
00894912002319BT10M5S8CBT10M5S8CBT10M5S8C2016-03-10
00894912002333BT5M05S8ABT5M05S8ABT5M05S8A2016-03-10
00894912002340BT5M05S8CBT5M05S8CBT5M05S8C2016-03-10
00894912002357BT8M05S8ABT8M05S8ABT8M05S8A2016-03-09
00894912002364BT8M05S8CBT8M05S8CBT8M05S8C2016-03-10
00894912002425T10M5S8CT10M5S8CT10M5S8C2016-03-10
00894912002449T5M05S8CT5M05S8CT5M05S8C2016-03-10
00894912002456T8M05S8CT8M05S8CT8M05S8C2016-03-10
00894912002975BT5M05S8ABT5M05S8ABT5M05S8A2016-07-06
00894912002432T2M20S8CT2M20S8CT2M20S8C2016-03-10
00894912002463T2M25N8AT2M25N8AT2M25N8A2016-03-10
00894912002876Pencil probeBP5M05S8ABP5M05S8A2016-06-29
00894912002890Pencil probeBP10M5S8ABP10M5S8A2016-06-29
00894912002883Pencil probeBP8M05S8ABP8M05S8A2018-04-10
00894912002036CTCT-4CT-42020-04-03
00894912002326BT2M20S8CBT2M20S8CBT2M20S8C2016-03-10
00894912002067PAUS2.0PAUS2.02025-01-01

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08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13