VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port

FDA UDI

Class II (US FDA UDI)

by Vortran Medical Technology 1, Inc.

Identity

Trade Name: VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port FDA UDI
Generic Name: Ultrasonic nebulizing system FDA UDI
Device Name: The PercussiveNEB 2.0 with Top Nebulizer Port is an intrapulmonary percussive treatment device that can incorporate a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions. FDA UDI
Model / Reference: 8040 FDA UDI
Description: The PercussiveNEB 2.0 with Top Nebulizer Port is an intrapulmonary percussive treatment device that can incorporate a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions. FDA UDI

Identifiers

Catalog Number: 8040 FDA UDI
Primary DI / UDI-DI: 10637320080404 FDA UDI
510(k) Number: K003684 FDA UDI
FDA Product Code: NHJ FDA UDI
GMDN Term: Ultrasonic nebulizing system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultrasonic nebulizing system

VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K003684 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vortran Medical Technology 1, Inc.

Sources (1)

FDA UDI 1db0aba4-d403-4b04-8faf-6fbcf223a9a6 36 fields · synced May 31, 2026