Identity
- Trade Name
- Oxyless FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis. FDA UDI
- Model / Reference
- CK84/14-F FDA UDI
- Description
- The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060493650002 FDA UDI
- 510(k) Number
- K150304 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 146 Milliliter FDA UDI
Category: Haemodialysis blood tubing set, single-use
Oxyless by Oxyless, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
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- Molded Products, Inc. — MOLDED PRODUCTS 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
- Oxyless, Ltd.
Sources (1)
- FDA UDI e3aae127-4699-4242-bcfd-0ddce3320c1f 36 fields · synced May 30, 2026