FDA.reportPublic FDA data

VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver

Primary DI
00817122020508
Brand
VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver
Company
VASCULAR TECHNOLOGY, INCORPORATED
Model
108800
Catalog number
108800
Device description
Part Number 108800, VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver
Published
2020-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K082870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082870000VTI INTRAOPERATIVE DOPPLER SYSTEMSVascular Technology Incorporated2008-10-28DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817122020638Direct MarkingGS10
00817122020508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817122020638008171220206388171220206380817122020638
00817122020508008171220205088171220205080817122020508

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(603)594-9700info@vti-online.com

Regulatory Flags#

DUNS number
161989343
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817122020607ROSI with Wings, Tubing Set1066101066102026-05-12
00817122020713ROSI xT with Wings, Exchangeable Tip Tubing Set1066501066502026-05-12
00817122020577Footswitch, Muting2014502014502024-01-25
00817122020584Pole Mount2014552014552024-01-25
10817122020048VTI 20 MHz Disposable Doppler Probe, Curved Tip, Box1028021028022016-09-20
1081712202022220MHz Micro Disposable Doppler Probe1086501086502017-09-05
10817122020338Mizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, box1386651386652016-09-20
00817122020065VTI Remotely Operated Suction & Irrigation System1064001064002016-09-20
10817122020192Mizuho 07-150-22 20 MHz Disposable Doppler Probe Curved Tip, Box1382301382302016-09-20
10817122020208Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box1386601386602016-09-20
10817122020260Mizuho 07-150-07 Disposable Doppler Probe for Neurosurgery, Box1382001382002016-09-20
10817122020284Mizuho 07-150-21 20 MHz Disposable Doppler Probe Straight, Box1382201382202016-09-20
00817122020140Mizuho Power Supply Desktop 90-264 VAC108110-MIZUHO108110-MIZUHO2016-09-20
0081712202040907-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power128910-AC128910-AC2016-09-20
00817122020133VTI Power Cord: Hospital US108110-US108110-US2016-09-20
00817122020058VTI Power Cord: Hospital Australia108110-AUS108110-AUS2016-09-20
00817122020089VTI Power Cord: Hospital Europe108110-EUROPE108110-EUROPE2016-09-20
00817122020096VTI Power Cord: Hospital Japan108110-JAPAN108110-JAPAN2016-09-20
00817122020102VTI Power Supply Desktop 90-264 VAC108110-SUPPLY108110-SUPPLY2016-09-20
00817122020126VTI Power Cord: Hospital United Kingdom108110-UK108110-UK2016-09-20

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