Identity
- Trade Name
- Hemo-Dial FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- MAGNESIUM CHLORIDE 12 GRAM PACKETS FDA UDI
- Model / Reference
- M12BX FDA UDI
- Description
- MAGNESIUM CHLORIDE 12 GRAM PACKETS FDA UDI
Identifiers
- Catalog Number
- M12BX FDA UDI
- Primary DI / UDI-DI
- 10857940006541 FDA UDI
- 510(k) Number
- K813388 FDA UDI
- FDA Product Code
- KPO FDA UDI
- GMDN Term
- Haemodialysis concentrate 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
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
- Weight — 3 Pound FDA UDI
Category: Haemodialysis concentrate
Hemo-Dial by Edlaw Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis concentrate.
- DIASOL — DIASOL INC · Class II
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- Di-Chem Hemodialysate Additive — Di-Chem, Incorporated · Class II
- CitraPure — Rockwell Medical · Class II
- Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
- DIASOL — DIASOL INC · Class II
- RenalPure — Rockwell Medical · Class II
- Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
Cleared under the same submission
K813388 also covers:
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edlaw Pharmaceuticals, Inc.
Sources (1)
- FDA UDI c6d311d2-521c-4c77-8867-0fefbddccc59 37 fields · synced May 30, 2026