Identity
- Trade Name
- Kosmos OTS iOS FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Kosmos Application loaded on an iPad. FDA UDI
- Model / Reference
- iOS 4.X FDA UDI
- Description
- Kosmos Application loaded on an iPad. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000823 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIDQD FDA UDIDPS FDA UDIQIH FDA UDI
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI870.1875 FDA UDI870.2340 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kosmos OTS iOS by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- EchoNous
Sources (1)
- FDA UDI b0fa7588-5e09-4206-9383-211495c4762e 34 fields · synced Jun 8, 2026