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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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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009973336
- DUNS Number
- —
Catalogue (123)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bacterial/Viral Filter | 301-435 | FDA UDI | Class II | Active |
| O2-Max | 313-8007X | FDA UDI | Class II | Active |
| DART-Reach | 301-REACH720 | FDA UDI | Class II | Active |
| ABC - Compact Breathing Circuit | C072323M1X1A4 | FDA UDI | Class I | Active |
| Whisper Soft | CS9411 | FDA UDI | Class II | Active |
| Aero-Sat Mini | 301-429 | FDA UDI | Class I | Active |
| ABC -Flex Tube System | F060323M3X1E4 | FDA UDI | Class I | Active |
| Whisper Soft | CS9412 | FDA UDI | Class II | Active |
| Pertrach | 301-D4554 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5735 | FDA UDI | Class II | Active |
| ABC - Duoflow Bi-lumen Breathing Circuit | D120323M1X1A4 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5803 | FDA UDI | Class II | Active |
| Pertrach | 301-D4559 | FDA UDI | Class II | Active |
| ABC - Pediatric Compact Breathing Circuit | PC12123M90000 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5734 | FDA UDI | Class II | Active |
| Pertrach | 301-D4550 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5582 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5739 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5677 | FDA UDI | Class II | Active |
| Pulmonary Function Filter | 301-436 | FDA UDI | Class II | Active |
| Pertrach | 301-D4558 | FDA UDI | Class II | Active |
| ABC - Uniflow Breathing Circuit | U096323M0X1A4 | FDA UDI | Class I | Active |
| ABC - Flex Tube System | F060323M0X1E5 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5740 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5810 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5802 | FDA UDI | Class II | Active |
| SealFlex | 4-005520-00 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5580 | FDA UDI | Class II | Active |
| Pertrach | 301-D4551 | FDA UDI | Class II | Active |
| Aero-Sat | 301-424 | FDA UDI | Class II | Active |
| ABC - Uniflow Breathing Circuit | U072323M0X100 | FDA UDI | Class I | Active |
| VentiSure2 | 301-5736 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5679 | FDA UDI | Class II | Active |
| Aero-Pro | 301-439 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5742 | FDA UDI | Class II | Active |
| Pertrach | 301-D4553 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5581 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5817 | FDA UDI | Class II | Active |
| ABC - Uniflow Breathing Circuit | U060323M1X1E4 | FDA UDI | Class I | Active |
| Fenem | 301-5534 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5813 | FDA UDI | Class II | Active |
| Aero-Sat | 301-414 | FDA UDI | Class II | Active |
| ABC - Compact Breathing Circuit | C120323M1X1E5 | FDA UDI | Class I | Active |
| ABC - Duoflow Bi-lumen Breathing Circuit | D072323M0X1A4 | FDA UDI | Class I | Active |
| DART-Reach | 301-REACH700 | FDA UDI | Class II | Active |
| VentiSure2 | 301-5818 | FDA UDI | Class II | Active |
| SealFlex | 4-005521-00 | FDA UDI | Class II | Active |
| Pertrach | 301-D4555 | FDA UDI | Class II | Active |
| ABC - Duoflow Bi-lumen Breathing Circuit | D72M317M1X1A4 | FDA UDI | Class I | Active |
| Disposable Pressure Manometer | 313-4000 | FDA UDI | Class II | Active |
Related Companies
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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. |