Identity
- Trade Name
- Tablo Cartridge FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- Tablo Cartridge with Needleless Infusion Ports FDA UDI
- Model / Reference
- PN-0002305 FDA UDI
- Description
- Tablo Cartridge with Needleless Infusion Ports FDA UDI
Identifiers
- Catalog Number
- CART-200 FDA UDI
- Primary DI / UDI-DI
- 00850001011075 FDA UDI
- 510(k) Number
- K140841 FDA UDI
- FDA Product Code
- FJK FDA UDI
- GMDN Term
- Haemodialysis blood tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tablo Cartridge by Outset Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140841 also covers:
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 16e3788a-59da-4686-b9cb-14c4f1ed7f2c 38 fields · synced Jun 8, 2026