FDA.reportPublic FDA data

VTI 8 MHZ Disposable Doppler Probe, Straight, Box

Primary DI
10817122020161
Brand
VTI 8 MHZ Disposable Doppler Probe, Straight, Box
Company
VASCULAR TECHNOLOGY, INCORPORATED
Model
108260
Catalog number
108260
Device description
Part Number 108260, VTI 8 MHZ Disposable Doppler Probe, Straight, Box
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
10817122020161PrimaryGS10
00817122020164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712202016110817122020161
00817122020164008171220201648171220201640817122020164

GMDN Terms#

Term, Definition table
TermDefinition
Invasive/noninvasive vascular ultrasound probeA hand-operated component of a vascular ultrasound system intended to be used to measure the flow of blood both invasively by being applied to the outside of an isolated blood vessel perioperatively, and noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a single-use device.

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
4
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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1081712202022220MHz Micro Disposable Doppler Probe1086501086502017-09-05
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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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