07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power 128910-AC

GUDID 00817122020409

Part Number 128910-AC, 07-150-08 Mizuho Doppler 8 MHz, Dual Channel AC Power

VASCULAR TECHNOLOGY, INCORPORATED

Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit

• Primary Device ID: 00817122020409
• NIH Device Record Key: f1ec5097-9ed3-48d6-a600-a7f05881a731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power
• Version Model Number: 128910-AC
• Catalog Number: 128910-AC
• Company DUNS: 161989343
• Company Name: VASCULAR TECHNOLOGY, INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(603)594-9700
• Email: info@vti-online.com
• Phone: +1(603)594-9700
• Email: info@vti-online.com
• Phone: +1(603)594-9700
• Email: info@vti-online.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817122020409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082870

FDA Product Code

• DPW: FLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by VASCULAR TECHNOLOGY, INCORPORATED

• 00817122020560 - VTI 8MHz TRANS-Q-TANEOUS INTRA OPERATIVE DOPPLER SYSTEM: 2024-02-02 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 0.5: 2024-02-02 Part Number: 201450, Footswitch, Mute, Doppler
• 00817122020584 - Pole Mount for use with VTI TQI Doppler, Gen 0.5: 2024-02-02 Part Number: 201455, Pole Mount
• 00817122020515 - Latching Foot Switch for Use with 106400: 2023-10-18 Part Number 201202, Foot Switch Latching Suction, for ROSI
• 00817122020522 - ROSI xT Tubing set for use with Exchangeable tips, Pouch: 2023-10-18 Part Number 106450, ROSI tubing set, Exchangeable tip. Each
• 10817122020048 - VTI 20 MHZ Disposable Doppler Probe, Curved Tip, Box: 2021-04-07 Part Number 102802, VTI 20 MHZ Disposable Doppler Probe Curved, Sterile, Box
• 10817122020154 - VTI 20 MHZ Disposable Doppler Probe, Straight, Box: 2021-04-07 Part Number 108200, VTI 20 MHZ Disposable Doppler Probe, Straight, Box
• 10817122020161 - VTI 8 MHZ Disposable Doppler Probe, Straight, Box: 2021-04-07 Part Number 108260, VTI 8 MHZ Disposable Doppler Probe, Straight, Box