Identity
- Trade Name
- CombiSet FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- Pre-pump, 8.0 mm, Home Hemo with prime bag FDA UDI
- Model / Reference
- 03-2962-3 FDA UDI
- Description
- Pre-pump, 8.0 mm, Home Hemo with prime bag FDA UDI
Identifiers
- Catalog Number
- 03-2962-3 FDA UDI
- Primary DI / UDI-DI
- 00840861100330 FDA UDI
- 510(k) Number
- K070049 FDA UDI
- FDA Product Code
- ONW FDA UDI
- GMDN Term
- Haemodialysis blood tubing set, single-use 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
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
Dimensions & Sizes
- Size
- Total Volume — 134 Milliliter FDA UDI
Category: Haemodialysis blood tubing set, single-use
CombiSet by Fresenius Medical Care Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis blood tubing set, single-use.
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- 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
- Lifemed Low Volume Tubing Set — Lifemed of California · Class II
Cleared under the same submission
K070049 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
- Fresenius Medical Care Holdings, Inc.
Sources (1)
- FDA UDI dfa1938b-6959-4afd-bba1-3e4ba2217ab2 37 fields · synced Jun 8, 2026