FDA.reportPublic FDA data

VTI Power Cord: Hospital US

Primary DI
00817122020133
Brand
VTI Power Cord: Hospital US
Company
VASCULAR TECHNOLOGY, INCORPORATED
Model
108110-US
Catalog number
108110-US
Device description
Part Number 108110-US, VTI Power Cord: Hospital US
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFLOWMETER, BLOOD, CARDIOVASCULAR
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

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
00817122020133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817122020133008171220201338171220201330817122020133

GMDN Terms#

Term, Definition table
TermDefinition
Invasive/noninvasive vascular ultrasound probeA sterile 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 non-invasively 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.

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
DM exempt
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
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
10817122020246Edwards FLO-002S Ultrasonic Blood Flow Detector Curved Probe, Box1283601283602016-09-20

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