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Sign in to claim this brandWhat ATOS MEDICAL INC. makes
Atos Medical Inc. manufactures tracheostomy-related devices, including non-reinforced, reusable tracheostomy tubes, tracheoesophageal speech valves for indwelling use, tracheostoma protective filters, and removable ambulatory skin-adherent patches. Their portfolio also covers tracheostomy tube neck holders (single-use), airway cleaning utensils (noninvasive, reusable), tracheostoma buttons, and accessories like shower shields. Additional products include adhesive solutions, dilators, and heat and moisture exchangers (HMEs) for tracheostomy care.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- atosmedical.com
- —
- —
- [email protected]
- Phone
- 800-217-0025
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 008224748
Catalogue (460)
Page 2 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Provox LaryButton Sizer Kit | 7690 | FDA UDI | Class I | Active |
| Provox TruTone Plus | 7444 | EUDAMEDFDA UDI | Class I | Active |
| Provox Vega Puncture Set 22.5Fr 12.5mm | 8149US | FDA UDI | Class II | Active |
| Provox TwistLock 17Fr | 8030 | FDA UDI | Class I | Active |
| Atos Medical | 2010-068 | FDA UDI | N/A | Unknown |
| Provox Vega Puncture Set 20Fr 8mm | 8144US | FDA UDI | Class II | Active |
| ProTrach® DualCare™ Set 22 | 7740 | FDA UDI | Class II | Unknown |
| Provox TruTone Emote | 7439 | EUDAMEDFDA UDI | Class I | Active |
| Provox Life LP Kit 14 - LT 10/55 | 6143 | FDA UDI | Class II | Active |
| Provox Life LaryTube 12/55 Standard with Ring | 7428 | FDA UDI | Class I | Active |
| Provox LaryTube 9/55 | 7607 | FDA UDI | Class I | Active |
| Freevent DualCare Speaking Valve | 7744 | EUDAMEDFDA UDI | Class II | Active |
| Provox Vega XtraSeal 17Fr 4mm | 8288 | FDA UDI | Class II | Active |
| Atos Medical | 9/36 | FDA UDI | N/A | Unknown |
| Provox® Vega™ XtraSeal™ | 22.5 Fr | FDA UDI | Class II | Unknown |
| Provox Coming Home Canada | 8224CA | FDA UDI | Class I | Unknown |
| Provox Life LaryTube 10/36 Fenestrated | 7433 | FDA UDI | Class I | Active |
| Provox Life LP Kit 4 - LT 12/36, 12/55 | 6133 | FDA UDI | Class II | Active |
| Provox Dilator | 7211 | FDA UDI | Class I | Active |
| Provox Adhesive FlexiDerm Round | 7253 | EUDAMEDFDA UDI | Class I | Active |
| Freevent DualCare Set 15 | 7741 | EUDAMEDFDA UDI | Class II | Active |
| Provox Life LaryTube 10/55 Fenestrated with Ring | 8053 | FDA UDI | Class I | Active |
| Provox NID 17, 10 mm | 7103 | FDA UDI | Class II | Active |
| Provox Dilator 17 | 7122 | FDA UDI | Class I | Active |
| Atos Medical | 2010C2-07E6 | FDA UDI | N/A | Unknown |
| Atos Medical | 12/55 | FDA UDI | N/A | Unknown |
| Atos Medical | 2010-067 | FDA UDI | N/A | Unknown |
| Atos Medical | 2010-054 | FDA UDI | N/A | Unknown |
| Provox Life LaryButton 18/8 | 8046 | FDA UDI | Class I | Active |
| Provox ActiValve Strong 12.5 mm | 7164 | FDA UDI | Class II | Active |
| Provox NID 17, 14 mm | 7105 | FDA UDI | Class II | Active |
| Provox Life Standard Adhesive Oval | 7461 | FDA UDI | Class I | Active |
| Provox Dilator | 8341 | FDA UDI | Class I | Active |
| Provox Vega Puncture Set 17Fr 10mm | 8141US | FDA UDI | Class II | Active |
| Provox XtraFlange 17 | 7277 | FDA UDI | Class II | Active |
| Provox LaryTube 9/55 with Ring | 7627 | FDA UDI | Class I | Active |
| Atos Medical | 8/55 | FDA UDI | N/A | Unknown |
| Provox® Vega™ | 22.5 Fr | FDA UDI | Class II | Unknown |
| Provox ActiValve Strong 10 mm | 7163 | FDA UDI | Class II | Active |
| Provox LaryTube 8/27 | 7601 | FDA UDI | Class I | Active |
| Atos Medical | 10/36 | FDA UDI | N/A | Unknown |
| Provox LaryButton 16/8 | 7673 | FDA UDI | Class I | Active |
| Provox2 Voice Prosthesis 15mm | 7224 | FDA UDI | Class II | Active |
| Provox Vega XtraSeal 20Fr 12.5mm | 8298 | FDA UDI | Class II | Active |
| Provox Larytube 8/55 | 7603 | FDA UDI | Class I | Active |
| Provox FlexiDerm Round (3pcs) | 8234 | FDA UDI | Class I | Unknown |
| Provox OptiDerm Oval (3 pcs) | 8237 | EUDAMEDFDA UDI | Class I | Active |
| Provox NID 17, 6 mm | 7101 | FDA UDI | Class II | Active |
| Provox LaryTube 8/36 | 7602 | FDA UDI | Class I | Active |
| Provox Life LaryTube 9/55 Standard with Ring | 7424 | FDA UDI | Class I | Active |
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