Identity
- Trade Name
- 10" Dialysis Tubing Extensions (Pair) FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- 10" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a male swivel luer lock connector on the one end and female luer lock connector on the other. A small pinch clamp is also provided on each tube segment. Protective caps are secured to each end to prevent product contamination and maintain sterility when the sterile pouch is opened. FDA UDI
- Model / Reference
- 1.5 FDA UDI
- Description
- 10" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a male swivel luer lock connector on the one end and female luer lock connector on the other. A small pinch clamp is also provided on each tube segment. Protective caps are secured to each end to prevent product contamination and maintain sterility when the sterile pouch is opened. FDA UDI
Identifiers
- Catalog Number
- 17-088 FDA UDI
- Primary DI / UDI-DI
- 16641670000825 FDA UDI
- 510(k) Number
- K833112 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Haemodialysis blood tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemodialysis blood tubing set, single-use
10" Dialysis Tubing Extensions (Pair) by Cardio Med Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis blood tubing set, single-use.
- 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
- Lifemed Low Volume Tubing Set — Lifemed of California · Class II
Cleared under the same submission
K833112 also covers:
- 1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector — Cardio Med Supplies, Inc.
- 1/2'' x 1/2'' Straight Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' Reducer Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 1/2'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x 3/8'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/2'' x 3/8'' x1/2'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' Tubing Adapter with Rotating Luer Lock — Cardio Med Supplies, Inc.
- 1/4'' Y Connector w/L.L. — Cardio Med Supplies, Inc.
- 1/4'' to I.V. Connector — Cardio Med Supplies, Inc.
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
- Cardio Med Supplies, Inc.
Sources (1)
- FDA UDI 0a39fc30-5bf0-42e0-a0a5-604c9c73e180 35 fields · synced May 30, 2026