Percussionaire

FDA UDI

Class II (US FDA UDI)

by Percussionaire Corporation

Identity

Trade Name: Percussionaire FDA UDI
Generic Name: Portable pneumatic ventilator FDA UDI
Device Name: TXP-Duotron, Vertical Orientation FDA UDI
Model / Reference: F00029-1 FDA UDI
Description: TXP-Duotron, Vertical Orientation FDA UDI

Identifiers

Catalog Number: S00026-1V FDA UDI
Primary DI / UDI-DI: 00849436000204 FDA UDI
510(k) Number: K905234 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Portable pneumatic ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Portable pneumatic ventilator

Percussionaire by Percussionaire Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable pneumatic ventilator.

Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
pNeuton — AIRON CORPORATION · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
pNeuton — AIRON CORPORATION · Class II
Emergent Respiratory — MDL SOLUTIONS INCORPORATED · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
PAHI VersalVent — Pan-America Hyperbarics, Inc. · Class II
CAREvent MRI — O-Two Medical Technologies Inc · Class II

Cleared under the same submission

K905234 also covers:

Percussionaire — Percussionaire Corporation

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

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

Manufacturer

Manufacturer: Percussionaire Corporation

Sources (1)

FDA UDI 89a313c0-28a7-407f-b2cd-2e1ed32b29ff 36 fields · synced Jun 8, 2026