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Vista-MX (Gold Edition)

FDA UDI

Class II (US FDA UDI)

by Vacumed

Identity

Trade Name
Vista-MX (Gold Edition) FDA UDI
Generic Name
Cardiopulmonary stress exercise monitoring system FDA UDI
Device Name
Vista Interface System FDA UDI
Model / Reference
17593 FDA UDI
Description
Vista Interface System FDA UDI

Identifiers

Catalog Number
17593 FDA UDI
Primary DI / UDI-DI
00850644007046 FDA UDI
510(k) Number
K864852 FDA UDI
FDA Product Code
BZL FDA UDI
GMDN Term
Cardiopulmonary stress exercise monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1730 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary stress exercise monitoring system

Vista-MX (Gold Edition) by Vacumed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary stress exercise monitoring system.

Cleared under the same submission

K864852 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vacumed

Sources (1)

  • FDA UDI a104ead9-8edd-48ed-90da-874bf8d409ff 36 fields · synced May 30, 2026