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Vision Ex5

FDA UDI

Class II (US FDA UDI)

by Avante

Identity

Trade Name
VISION EX5 FDA UDI
Generic Name
Transportable medical equipment stand, non-powered FDA UDI
Device Name
DRE Vision EX5, WALL MOUNT FDA UDI
Model / Reference
DRE 061422 FDA UDI
Description
DRE Vision EX5, WALL MOUNT FDA UDI

Identifiers

Primary DI / UDI-DI
00815871022248 FDA UDI
510(k) Number
K140812 FDA UDI
FDA Product Code
FSY FDA UDI
GMDN Term
Transportable medical equipment stand, non-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transportable medical equipment stand, non-powered

Vision Ex5 by Avante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transportable medical equipment stand, non-powered.

Cleared under the same submission

K140812 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avante

Sources (1)

  • FDA UDI 9fb55151-d8c4-42d8-a976-bdb2f0598419 34 fields · synced May 30, 2026