Identity
- Trade Name
- Tablo Hemodialysis Console FDA UDI
- Generic Name
- Haemodialysis system, institutional FDA UDI
- Model / Reference
- PN-0000850 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001011006 FDA UDI
- 510(k) Number
- K140866 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system, institutional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Commercial Distribution
- 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
Category: Haemodialysis system, institutional
Tablo Hemodialysis Console by Outset Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Outset Medical, Inc.
Sources (1)
- FDA UDI 473771a8-6806-4e05-8ac2-1ddf16fd5c07 35 fields · synced Jun 8, 2026