VORTRAN PercussiveNEB

FDA UDI

Class II (US FDA UDI)

by Vortran Medical Technology 1, Inc.

Identity

Trade Name: VORTRAN PercussiveNEB FDA UDI
Generic Name: Ultrasonic nebulizing system FDA UDI
Device Name: The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home FDA UDI
Model / Reference: PNB-4030 FDA UDI
Description: The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home FDA UDI

Identifiers

Catalog Number: PNB-4030 FDA UDI
Primary DI / UDI-DI: 10637320040309 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 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 e1843de4-b1d1-4056-96a9-77a080e725dd 36 fields · synced May 30, 2026