← Back to catalogue

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 vest FDA UDI
Device Name
LTU SmartVest Wrap® - S-Small FDA UDI
Model / Reference
LTUSW-17/25 FDA UDI
Description
LTU SmartVest Wrap® - S-Small FDA UDI

Identifiers

Catalog Number
LTUSW-17/25 FDA UDI
Primary DI / UDI-DI
B102060145S1300 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Chest-oscillation airway secretion-clearing system vest 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chest-oscillation airway secretion-clearing system vest

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 vest.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Electromed, Inc.

Sources (1)

  • FDA UDI 38408166-916b-4431-adaa-b28eb7c2c152 34 fields · synced May 30, 2026