Identity
- Trade Name
- CitraSure™ FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Model / Reference
- 28-0600-0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102396 FDA UDI
- 510(k) Number
- K231534 FDA UDI
- FDA Product Code
- NII FDA UDI
- GMDN Term
- Medical device disinfection agent 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
Dimensions & Sizes
- Size
- Total Volume — 5 Liter FDA UDI
Category: Medical device disinfection agent
CitraSure™ by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231534 also covers:
- 5008X Fluid Sampling Accessory — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X Hemodialysis Machine — Fresenius Medical Care Renal Therapies Group, LLC
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
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA UDI a67c49ee-e926-4643-a68e-318c91ea4300 36 fields · synced May 30, 2026