Identity
- Trade Name
- HMB32 FDA UDI
- Generic Name
- Haemodialysis dialysate solution FDA UDI
- Device Name
- dialysis solution,ml 500+4500 FDA UDI
- Model / Reference
- MD088 FDA UDI
- Description
- dialysis solution,ml 500+4500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 38051411600351 FDA UDI
- FDA Product Code
- KPO FDA UDI
- GMDN Term
- Haemodialysis dialysate solution 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
Dimensions & Sizes
- Size
- Total Volume — 5000 Milliliter FDA UDI
Category: Haemodialysis dialysate solution
Hmb32 by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis dialysate solution.
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- PRISMASATE — Baxter Healthcare Corp · 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
- Mozarc Medical US LLC
Sources (1)
- FDA UDI f390b616-25a8-4a03-90cf-d576503fa617 36 fields · synced Jun 8, 2026