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Percussionaire

FDA UDI

Class II (US FDA UDI)

by Percussionaire Corporation

Identity

Trade Name
Percussionaire FDA UDI
Generic Name
Transport pneumatic high-frequency ventilator FDA UDI
Device Name
Sinusoidal Bronchotron and Universal Monitron Transport, French. FDA UDI
Model / Reference
F00038-2FR FDA UDI
Description
Sinusoidal Bronchotron and Universal Monitron Transport, French. FDA UDI

Identifiers

Catalog Number
S00033-2FR FDA UDI
Primary DI / UDI-DI
00849436000471 FDA UDI
510(k) Number
K905235 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Transport pneumatic high-frequency ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

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

Cleared under the same submission

K905235 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Percussionaire Corporation

Sources (1)

  • FDA UDI b1fafb18-3b73-4fc7-a0e6-741ee0061f9e 37 fields · synced Jun 1, 2026