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Vivio System App

FDA UDI

Class II (US FDA UDI)

by Ventric Health

Identity

Trade Name
Vivio System App FDA UDI
Generic Name
Cardiac mapping system application software FDA UDI
Model / Reference
VA 1.0 FDA UDI

Identifiers

Primary DI / UDI-DI
00850044849024 FDA UDI
510(k) Number
K223905 FDA UDI
FDA Product Code
QUO FDA UDI
GMDN Term
Cardiac mapping system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac mapping system application software

Vivio System App by Ventric Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system application software.

Cleared under the same submission

K223905 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventric Health

Sources (1)

  • FDA UDI 03c802c0-0637-4a08-850d-113359053fa2 34 fields · synced May 31, 2026