VTI Doppler Transceiver 20 MHz Single Channel 108400

GUDID 00817122020324

Part Number 108400 VTI Doppler Transceiver 20 MHz Singel Channel

VASCULAR TECHNOLOGY, INCORPORATED

Vascular ultrasound system control unit
Primary Device ID00817122020324
NIH Device Record Keyd64022a7-f644-4cb7-a280-582ffc350032
Commercial Distribution StatusIn Commercial Distribution
Brand NameVTI Doppler Transceiver 20 MHz Single Channel
Version Model Number108400
Catalog Number108400
Company DUNS161989343
Company NameVASCULAR TECHNOLOGY, INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com
Phone+1(603)594-9700
Emailinfo@vti-online.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100817122020324 [Primary]
GS100817122020621 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by VASCULAR TECHNOLOGY, INCORPORATED

00817122020560 - VTI 8MHz TRANS-Q-TANEOUS INTRA OPERATIVE DOPPLER SYSTEM2024-02-02 Part Number: 108850, Gen 0.5, VTI 8MHz TRANS-Q-TANEOUS INTRA OPERATIVE DOPPLER SYSTEM
00817122020577 - Footswitch, Mute, for use with VTI TQI Doppler Gen 0.52024-02-02 Part Number: 201450, Footswitch, Mute, Doppler
00817122020584 - Pole Mount for use with VTI TQI Doppler, Gen 0.52024-02-02 Part Number: 201455, Pole Mount
00817122020515 - Latching Foot Switch for Use with 1064002023-10-18 Part Number 201202, Foot Switch Latching Suction, for ROSI
00817122020522 - ROSI xT Tubing set for use with Exchangeable tips, Pouch2023-10-18 Part Number 106450, ROSI tubing set, Exchangeable tip. Each
10817122020048 - VTI 20 MHZ Disposable Doppler Probe, Curved Tip, Box2021-04-07 Part Number 102802, VTI 20 MHZ Disposable Doppler Probe Curved, Sterile, Box
10817122020154 - VTI 20 MHZ Disposable Doppler Probe, Straight, Box2021-04-07 Part Number 108200, VTI 20 MHZ Disposable Doppler Probe, Straight, Box
10817122020161 - VTI 8 MHZ Disposable Doppler Probe, Straight, Box2021-04-07 Part Number 108260, VTI 8 MHZ Disposable Doppler Probe, Straight, Box

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.