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DeVilbiss Healthcare LLC.

Last updated September 17, 2026

Information

Country: US
Address: 100 Devilbiss Dr, SOMERSET, PA, 15501
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2515872
DUNS Number: —

Catalogue (314)

Page 3 of 7

Device	Model / Reference	Registries	Class	Status
DeVilbiss	3655LTPL-TCH	FDA UDI	Class II	Unknown
DeVilbiss	9354GL	FDA UDI	Class II	Unknown
DeVilbiss	DV57UK-HH	FDA UDI	Class II	Unknown
DeVilbiss	PD1000A-CAN-E	FDA UDI	Class II	Unknown
DeVilbiss	DV55UK-UP-HH	FDA UDI	Class II	Unknown
DeVilbiss	7310PR-S	FDA UDI	Class II	Unknown
DeVilbiss	DV57D	FDA UDI	Class II	Unknown
DeVilbiss	DV55D-HH	FDA UDI	Class II	Unknown
DeVilbiss	535D-E-CF	FDA UDI	Class II	Active
DeVilbiss	125D-XB	FDA UDI	Class II	Active
DeVilbiss	151	FDA UDI	Class I	Unknown
DeVilbiss	DV53D-HH	FDA UDI	Class II	Unknown
DeVilbiss	535D-C-870	FDA UDI	Class II	Active
DeVilbiss	DV53D-S	FDA UDI	Class II	Unknown
DeVilbiss	7305D-632	FDA UDI	Class II	Unknown
DeVilbiss	DV64E	FDA UDI	Class II	Unknown
DeVilbiss	PD1000A-ML6	FDA UDI	Class II	Unknown
DeVilbiss	DV55D-R	FDA UDI	Class II	Unknown
iGo2	125A	FDA UDI	Class II	Active
DeVilbiss	3655PL-NL	FDA UDI	Class II	Unknown
DeVilbiss	DV54UK-P	FDA UDI	Class II	Unknown
DeVilbiss	DV54D	FDA UDI	Class II	Unknown
DeVilbiss	7305D-D-EXF	FDA UDI	Class II	Active
DeVilbiss	DV6WM-NA	FDA UDI	Class II	Unknown
DeVilbiss	DV55SE-HH	FDA UDI	Class II	Unknown
DeVilbiss	DV57BR-HH	FDA UDI	Class II	Unknown
DeVilbiss	3655PL-FTR	FDA UDI	Class II	Unknown
DeVilbiss	DV57SE	FDA UDI	Class II	Unknown
DeVilbiss	535D-D-CF	FDA UDI	Class II	Active
DeVilbiss	125D-BT	FDA UDI	Class II	Active
DeVilbiss	DV53BR-HH	FDA UDI	Class II	Unknown
DeVilbiss	DV54D-HH-LA	FDA UDI	Class II	Unknown
DeVilbiss	DV6C	FDA UDI	Class II	Unknown
DeVilbiss	3655PL-VA	FDA UDI	Class II	Unknown
DeVilbiss	DV51D-S	FDA UDI	Class II	Unknown
DeVilbiss	9352gs	FDA UDI	Class II	Unknown
DeVilbiss	3655D	FDA UDI	Class II	Unknown
DeVilbiss	3655LTPL-THED	FDA UDI	Class II	Unknown
DeVilbiss	DV63D	FDA UDI	Class II	Unknown
DeVilbiss	DV56D-HH-HT	FDA UDI	Class II	Unknown
DeVilbiss	7314D-NE	FDA UDI	Class II	Unknown
DeVilbiss	DV53SE	FDA UDI	Class II	Unknown
DeVilbiss	DV55D-HH-S	FDA UDI	Class II	Unknown
DeVilbiss	DV6PD	FDA UDI	Class II	Unknown
DeVilbiss	PD1000A-E	FDA UDI	Class II	Unknown
DeVilbiss	DV56D-HH	FDA UDI	Class II	Unknown
DeVilbiss	7305AP-632	FDA UDI	Class II	Unknown
DeVilbiss	7314P-U	FDA UDI	Class II	Unknown
DeVilbiss	3655LTPL-ARC	FDA UDI	Class II	Unknown
DeVilbiss	DV57BR	FDA UDI	Class II	Unknown

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 9, 2023	Z-1558-2023	—	open, classified	The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Nov 18, 2022	Z-0724-2023	—	open, classified	The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
Sep 19, 2022	Z-0229-2023	—	open, classified	An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
May 23, 2016	Z-2246-2016	—	terminated	A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
May 13, 2014	Z-1949-2014	—	terminated	A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
Mar 7, 2013	Z-2319-2013	—	terminated	End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.