Identity
- Trade Name
- Bicarbonate Spare Connectors Set FDA UDI
- Generic Name
- Haemodialysis system dialysate delivery set FDA UDI
- Model / Reference
- SC-14918 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060497260153 FDA UDI
- 510(k) Number
- K222067 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system dialysate delivery set 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
No
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 system dialysate delivery set
Bicarbonate Spare Connectors Set by Quanta Dialysis Technologies, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system dialysate delivery set.
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Dialysate Cartridge — Quanta Dialysis Technologies, Ltd. · Class II
Cleared under the same submission
K222067 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
- Quanta Dialysis Technologies, Ltd.
Sources (1)
- FDA UDI 9739c6c4-ce16-4728-8fac-d16a0e2fe1f7 33 fields · synced May 30, 2026