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Sign in to claim this brandEngineered Medical Systems, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3325 Appling Rd, Bartlett, TN, 38133
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009973336
- DUNS Number
- —
Catalogue (123)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Whisper Soft | CS9415 | FDA UDI | Class II | Active |
| Whisper Soft | CS9409 | FDA UDI | Class II | Active |
| Pertrach | 301-D4557 | FDA UDI | Class II | Active |
| Dart | 2170-20100 | FDA UDI | Class I | Active |
| ABC - Compact Breathing Circuit | C120323M0X1A4 | FDA UDI | Class I | Active |
| Aero-Sat | 301-413 | FDA UDI | Class II | Active |
| Pertrach | 301-D4552 | FDA UDI | Class II | Active |
| ABC - Compact Breathing Circuit | C120323M0X1C5 | FDA UDI | Class I | Active |
| Whisper Soft | CS9410 | FDA UDI | Class II | Active |
| AccuPAP | 301-6003 | FDA UDI | Class II | Active |
| ABC - Pediatric Compact Breathing Circuit | PC12113M0X500 | FDA UDI | Class I | Active |
| ABC - Uniflow Breathing Circuit | U072323M0X1A4 | FDA UDI | Class I | Active |
| Whisper Soft | CS9413 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5737 | FDA UDI | Class II | Active |
| AccuPAP | 301-6001 | FDA UDI | Class II | Active |
| Whisper Soft | CS9408 | FDA UDI | Class II | Active |
| APV- Adjustable PEEP Valve | 301-5584 | FDA UDI | Class II | Active |
| Dart | 2170-20150 | FDA UDI | Class I | Active |
| Dpm | 301-5558 | FDA UDI | Class II | Active |
| Aero-T+ | 301-401 | FDA UDI | Class I | Active |
| Pertrach | 301-D4556 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5680 | FDA UDI | Class II | Active |
| Aero-Pro | 301-418 | FDA UDI | Class II | Active |
| Aero-Pro | 301-431 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5812 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5811 | FDA UDI | Class II | Active |
| AccuPAP | 301-6000 | FDA UDI | Class II | Active |
| Aero-Sat | 301-423 | FDA UDI | Class II | Active |
| Aero-Sat | 301-422 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5579 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5800 | FDA UDI | Class II | Active |
| ABC - Uniflow Breathing Circuit | U072323M0X1E5 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5678 | FDA UDI | Class II | Active |
| Aero-Sat | 301-427 | FDA UDI | Class I | Active |
| A-Pep | 301-6200 | FDA UDI | Class II | Active |
| DART-Reach | 301-REACH600 | FDA UDI | Class II | Active |
| ABC - Compact Breathing Circuit | C120323M0X1E5 | FDA UDI | Class I | Active |
| Aero-Pro | 301-412 | FDA UDI | Class II | Active |
| ABC - Duoflow Bi-lumen Breathing Circuit | D072323M2X1E4 | FDA UDI | Class I | Active |
| Fenem | 301-5585 | FDA UDI | Class II | Active |
| Dart | 2170-20300 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5726 | FDA UDI | Class II | Active |
| Whisper Soft | CS9414 | FDA UDI | Class II | Active |
| ABC - Flex Tube System | F96M317M0X1A4 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5911 | FDA UDI | Class II | Active |
| Aero-Pro | 301-411 | FDA UDI | Class II | Active |
| AccuPAP | 301-6002 | FDA UDI | Class II | Active |
| Aero-Sat | 301-437 | FDA UDI | Class II | Active |
| ABC - Duoflow Bi-lumen Breathing Circuit | D12M317M1X1A4 | FDA UDI | Class I | Active |
| Modification To Engineered Medical Systems Disposable Manual Resuscitator With Co2 Detection | K991955 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
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 |
|---|---|---|---|---|
| Sep 12, 2011 | Z-1058-2013 | — | terminated | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |