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SmartVest

FDA UDI

Class II (US FDA UDI)

by Electromed, Inc.

Identity

Trade Name
SmartVest FDA UDI
Generic Name
Chest-oscillation airway secretion-clearing system generator FDA UDI
Device Name
Electromed SmartVest Clearway Air Pulse Generator Demo FDA UDI
Model / Reference
Clearway Demo FDA UDI
Description
Electromed SmartVest Clearway Air Pulse Generator Demo FDA UDI

Identifiers

Catalog Number
125003-S-031 FDA UDI
Primary DI / UDI-DI
B102125003S0311 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Chest-oscillation airway secretion-clearing system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5665 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chest-oscillation airway secretion-clearing system generator

SmartVest by Electromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chest-oscillation airway secretion-clearing system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Electromed, Inc.

Sources (1)

  • FDA UDI e7ef3bab-76a6-480f-9095-6ff93a6fb261 34 fields · synced Jun 8, 2026