AVVIGO™ Guidance System II

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: AVVIGO™ Guidance System II FDA UDI
Generic Name: Cardiovascular ultrasound imaging system FDA UDI
Device Name: Guidance System FDA UDI
Model / Reference: H749009881CZ0 FDA UDI
Description: Guidance System FDA UDI

Identifiers

Primary DI / UDI-DI: 00191506015176 FDA UDI
FDA Product Code: IYO FDA UDI
DSK FDA UDI
ITX FDA UDI
DQK FDA UDI
GMDN Term: Cardiovascular ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
870.1110 FDA UDI
892.1570 FDA UDI
870.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiovascular ultrasound imaging system

AVVIGO™ Guidance System II by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular ultrasound imaging system.

Vivid — GE Medical Systems (China) Co., Ltd. · Class II
SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
Medistim System Activation Card — Medi-Stim Asa · Class II
Medistim MiraQ Vascular System — Medi-Stim Asa · Class II
Medistim MiraQ Vascular System — Medi-Stim Asa · Class II
Vivid — Ge Vingmed Ultrasound · Class II
SmartMap Pressure System — VOLCANO CORPORATION · Class II
Medistim System Activation Card — Medi-Stim Asa · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 67858c8f-4f88-4414-8693-a30ab00847f2 33 fields · synced May 30, 2026