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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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2515872
- DUNS Number
- —
Catalogue (314)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DeVilbiss | DV51D-R | FDA UDI | Class II | Unknown |
| DeVilbiss | 7305D-D | FDA UDI | Class II | Active |
| DeVilbiss | 7305P-D | FDA UDI | Class II | Active |
| DeVilbiss | 7314D-D | FDA UDI | Class II | Active |
| DeVilbiss | DV53SE-HH | FDA UDI | Class II | Unknown |
| DeVilbiss | PD1000A-M4 | FDA UDI | Class II | Unknown |
| DeVilbiss | DV53D-LA | FDA UDI | Class II | Unknown |
| DeVilbiss | DV57D-HH-LA | FDA UDI | Class II | Unknown |
| DeVilbiss | 535D-D-870 | FDA UDI | Class II | Active |
| DeVilbiss | DV53UK | FDA UDI | Class II | Unknown |
| DeVilbiss | 535I-C-CF | FDA UDI | Class II | Unknown |
| DeVilbiss | 1025KS | FDA UDI | Class II | Unknown |
| DeVilbiss | 3655LTR | FDA UDI | Class II | Active |
| DeVilbiss | DV57D-S | FDA UDI | Class II | Unknown |
| DeVilbiss | 535I-ML6-CF | FDA UDI | Class II | Unknown |
| DeVilbiss | 7314D-LA | FDA UDI | Class II | Unknown |
| DeVilbiss | DV51SE-HH | FDA UDI | Class II | Unknown |
| DeVilbiss | 535C-D-870 | FDA UDI | Class II | Unknown |
| DeVilbiss | 125D | FDA UDI | Class II | Active |
| DeVilbiss | 3655PL-HCM1 | FDA UDI | Class II | Unknown |
| DeVilbiss | 3655LTPL-WF | FDA UDI | Class II | Unknown |
| DeVilbiss | DV57D-HH-S | FDA UDI | Class II | Unknown |
| DeVilbiss | DV55D-HH-HT | FDA UDI | Class II | Unknown |
| DeVilbiss | 3655PL-L | FDA UDI | Class II | Unknown |
| DeVilbiss | 3655SE | FDA UDI | Class II | Unknown |
| DeVilbiss | DV5HH | FDA UDI | Class II | Unknown |
| DeVilbiss | PD1000A-I-D | FDA UDI | Class II | Unknown |
| DeVilbiss iFill | 535I | FDA UDI | Class II | Unknown |
| Devilbiss Model 1400d (oxygen Conserving Device) | K890141 | FDA 510(k) | Class II | Active |
| Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | K172648 | FDA 510(k) | Class II | Active |
| Devilbiss 8650d | K963349 | FDA 510(k) | Class II | Active |
| Devilbiss Model 5650 Pulmo-Aide | K923888 | FDA 510(k) | Class II | Active |
| Devilbiss Ap-50 Compressor/Nebulizer | K900602 | FDA 510(k) | Class II | Active |
| Devilbiss Model 6300d | K896090 | FDA 510(k) | Class I | Active |
| 5 Lpm Oxygen Concentrator | K953815 | FDA 510(k) | Class II | Active |
| Devilbiss Model 4650 Compressor Neubulizer | K931015 | FDA 510(k) | Class II | Active |
| DeVilbiss DV6WM Wireless Modem | K152810 | FDA 510(k) | Class II | Active |
| Oxygen Sensing Device, Modification | K913392 | FDA 510(k) | Class II | Active |
| Devilbiss Smartlink Ii System | K140880 | FDA 510(k) | Class II | Active |
| Devilbiss Model 8500d And 8500d-608 | K894244 | FDA 510(k) | Class I | Active |
| Jet Nebulizer | K952249 | FDA 510(k) | Class II | Active |
| Pulse Dose Series | K961126 | FDA 510(k) | Class II | Active |
| Devilbiss Intellipap / Sleepcube Auto Bilevel | K112220 | FDA 510(k) | Class II | Active |
| DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | K250805 | FDA 510(k) | Class II | Active |
| Keystone Concentrator, Model Pv5l | K924152 | FDA 510(k) | Class II | Active |
| Devilbiss Model 7427d | K913316 | FDA 510(k) | Class II | Active |
| Devilbiss Model 7351d Revitalizer Cpap System | K893388 | FDA 510(k) | Class II | Active |
| Devilbiss Model 5500 | K946095 | FDA 510(k) | Class II | Active |
| DeVilbiss Intellipap2/DeVilbiss BLUE | K143677 | FDA 510(k) | Class II | Active |
| Model #7354 | K950849 | FDA 510(k) | Class II | Active |
Related Companies
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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. |