Identity
- Trade Name
- Nipro Set Blood Tubing Set FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- Blood Tubing Set for use with the SURDIAL DX Hemodialysis System FDA UDI
- Model / Reference
- A430/V912 FDA UDI
- Description
- Blood Tubing Set for use with the SURDIAL DX Hemodialysis System FDA UDI
Identifiers
- Catalog Number
- BL+A430/V912 FDA UDI
- Primary DI / UDI-DI
- 00383790008808 FDA UDI
- FDA Product Code
- KDI 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
Category: Haemodialysis blood tubing set, single-use
Nipro Set Blood Tubing Set by Nipro Medical Corporation — 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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- 5008X — Fresenius Medical Care Renal Therapies Group, LLC · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Lifemed Low Volume Tubing Set — Lifemed of California · Class II
- CombiSet — Fresenius Medical Care Holdings, Inc. · Class II
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
- Nipro Medical Corporation
Sources (1)
- FDA UDI 50145193-0bf3-48a5-b3c2-fb4ea782cdd9 35 fields · synced Jun 8, 2026