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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 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Provox Life LaryButton 14/18 | 8043 | FDA UDI | Class I | Active |
| Atos Medical | 10/36 | FDA UDI | N/A | Unknown |
| Provox Life LaryTube 8/55 Standard with Ring | 7422 | FDA UDI | Class I | Active |
| Provox Life LaryButton 12/18 | 8041 | FDA UDI | Class I | Active |
| Provox FenestrationPunch | 7654 | FDA UDI | Class I | Unknown |
| Provox LaryClip | 7669 | FDA UDI | Class I | Active |
| Provox Life LP Kit 9 - LT 8/36, 8/55 | 6138 | FDA UDI | Class II | Active |
| Provox Life LaryTube 10/55 Standard | 7417 | FDA UDI | Class I | Active |
| Provox Life FreeHands FlexiVoice Set Plus | 8210 | FDA UDI | Class II | Active |
| Provox Life Sensitive Adhesive Oval | 7464 | FDA UDI | Class I | Active |
| Provox Vega XtraSeal 22.5Fr 15mm | 8305 | FDA UDI | Class II | Active |
| Provox Life LP Kit 7 - LT 10/36, 10/55 | 6136 | FDA UDI | Class II | Active |
| Provox NID 20, 14 mm | 7115 | FDA UDI | Class II | Active |
| Provox® Vega™ XtraSeal™ | 17 Fr | FDA UDI | Class II | Unknown |
| Provox Vega 22.5Fr 6mm | 8283 | FDA UDI | Class II | Active |
| Provox StabiliBase OptiDerm (15 pcs) | 7318 | FDA UDI | Class I | Active |
| Provox® Vega™ XtraSeal™ | 20 Fr | FDA UDI | Class II | Unknown |
| Provox StabiliBase OptiDerm (3pcs) | 7328 | FDA UDI | Class I | Unknown |
| Provox LaryButton 12/18 | 7685 | FDA UDI | Class I | Active |
| Provox Vega 20Fr 6mm | 8277 | FDA UDI | Class II | Active |
| Provox® Vega™ | 20 Fr | FDA UDI | Class II | Unknown |
| Provox® Vega™ | 17 Fr | FDA UDI | Class II | Unknown |
| Provox NID 17, 12 mm | 7104 | FDA UDI | Class II | Active |
| Provox Cleaning Towel 10-p | 7244 | FDA UDI | Class I | Active |
| Provox Life Day & Night Experience Plus | 8062 | FDA UDI | Class I | Active |
| Provox FlexiDerm Oval (3 pcs) | 8235 | FDA UDI | Class I | Active |
| Provox Life LaryTube 12/27 Standard | 7418 | FDA UDI | Class I | Active |
| Provox® FreeHands HME® Replacement Device | 7722 | FDA UDI | Class II | Unknown |
| Provox Life LaryTube 8/36 Fenestrated with Ring | 8048 | FDA UDI | Class I | Active |
| Provox Measure Flanges | 7271 | FDA UDI | Class I | Active |
| Provox® Vega™ | 22.5 Fr | FDA UDI | Class II | Unknown |
| Provox® FreeHands HME® Adjustment Kit | 7719 | FDA UDI | Class II | Unknown |
| Provox Measure | 7270 | FDA UDI | Class I | Unknown |
| Provox Life LaryTube 12/55 Fenestrated | 7436 | FDA UDI | Class I | Active |
| Provox Brush | 7204 | FDA UDI | Class I | Active |
| Provox NID 20, 8 mm | 7112 | FDA UDI | Class II | Active |
| Freevent XtraCare Blue (30 pcs) | 7768 | FDA UDI | Class I | Active |
| Provox Capsule 22.5Fr | 7797 | EUDAMEDFDA UDI | Class I | Active |
| Provox Life Standard Experience Plus | 8067 | FDA UDI | Class I | Active |
| Provox Life Protect HME Experience | 8074 | EUDAMEDFDA UDI | Class I | Active |
| Provox LaryTube 9/27 | 7605 | FDA UDI | Class I | Active |
| Provox Tracheofix | 1 strip beige 38x63 | EUDAMEDFDA UDI | Class I | Active |
| Provox Vega Puncture Set 17Fr 8mm | 8140US | FDA UDI | Class II | Active |
| Provox LaryTube 10/36 with Ring | 7628 | FDA UDI | Class I | Active |
| Provox Wipes | 8243 | EUDAMEDFDA UDI | Class I | Active |
| Provox NID 20, 18 mm | 7116 | FDA UDI | Class II | Active |
| Provox Life LaryTube 9/36 Fenestrated | 7431 | FDA UDI | Class I | Active |
| Provox® Vega™ XtraSeal™ | 22.5 Fr | FDA UDI | Class II | Unknown |
| TrachPhone (5 pcs) | 7723 | FDA UDI | Class I | Active |
| Provox® FreeHands HME® Replacement Device Strong | Strong | FDA UDI | Class II | Unknown |
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