Identity
- Trade Name
- EXALIS FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Device Name
- Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data FDA UDI
- Model / Reference
- 113297 FDA UDI
- Description
- Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data FDA UDI
Identifiers
- Catalog Number
- 113297 FDA UDI
- Primary DI / UDI-DI
- 07332414106126 FDA UDI
- 510(k) Number
- K083158 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Exalis by Gambro Dasco Spa — 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
- Gambro Dasco Spa
Sources (1)
- FDA UDI 87defaf8-654e-4f4e-b470-eb469c854b60 37 fields · synced May 30, 2026