Identity
- Trade Name
- Tablo Cartridge FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Model / Reference
- DWG-3008 FDA UDI
Identifiers
- Catalog Number
- CART-100 FDA UDI
- Primary DI / UDI-DI
- 00850001011013 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
- 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
Category: Haemodialysis blood tubing set, single-use
Tablo Cartridge by Outset Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis blood tubing set, single-use.
- 10" Dialysis Tubing Extensions (Pair) — Cardio Med Supplies, Inc. · Class II
- CombiSet — Fresenius Medical Care Holdings, Inc. · Class II
- Hemodialysis Bloodlines — B. BRAUN MEDICAL INC. · Class II
- SAMI Hemofiltration Cassette — Dialco Medical Inc · Class II
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC · Class II
- NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION · Class II
- Nipro Set Blood Tubing Set — NIPRO MEDICAL CORPORATION · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
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 bf24d426-f8ad-4465-abec-5b14d3ebb89e 36 fields · synced May 30, 2026