Identity
- Trade Name
- Recirculation Adapter/Priming Connector FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime. FDA UDI
- Model / Reference
- 106283 FDA UDI
- Description
- This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime. FDA UDI
Identifiers
- Catalog Number
- 106283 FDA UDI
- Primary DI / UDI-DI
- 07332414055189 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
Recirculation Adapter/Priming Connector by Gambro Renal Products, S.A. de C.V. — 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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- 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
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
- Gambro Renal Products, S.A. de C.V.
Sources (1)
- FDA UDI d1105f7a-c208-408f-8107-19e51ce4d1e1 36 fields · synced Jun 1, 2026