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Sign in to claim this brandDeVilbiss Healthcare LLC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 100 Devilbiss Dr, SOMERSET, PA, 15501
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2515872
- DUNS Number
- —
Catalogue (314)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sleeper Mask System | K904344 | FDA 510(k) | Class II | Active |
| Devilbiss Model 7352 Series | K904766 | FDA 510(k) | Class II | Active |
| 3 Lpm Oxygen Concentrator | K952037 | FDA 510(k) | Class II | Active |
| Compressor/Nebulizer #3650 | K970289 | FDA 510(k) | Class II | Active |
| Devilbiss Model 7351 Series | K894424 | FDA 510(k) | Class II | Active |
| Model 7355 | K952491 | FDA 510(k) | Class II | Active |
| DeVilbiss 5 Liter Oxygen Concentrator (555) | K253549 | FDA 510(k) | Class II | Active |
| Cpap Mask | K894690 | FDA 510(k) | Class II | Active |
| Devilbiss Model 6610d | K894441 | FDA 510(k) | Class I | Active |
| Devilbiss Model Pv02 Series | K896457 | FDA 510(k) | Class II | Active |
| Devilbiss Model 5000 | K911896 | FDA 510(k) | Class II | Active |
| Model# 7500 Surveyor | K944611 | FDA 510(k) | Class II | Active |
| Seal Ring For Nasal Cpap | K921499 | FDA 510(k) | Class I | Active |
| Continuous Positive Airway Pressure Cpap System | K935979 | FDA 510(k) | Class II | Active |
Related Companies
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No authorised representatives on record.
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Authorities
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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. |