Identity
- Trade Name
- Dialyzer Dialysate QD to 3/8 in.NPT FDA UDI
- Generic Name
- Haemodialysis dialysate central supply system FDA UDI
- Model / Reference
- D300-0108 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858293006793 FDA UDI
- FDA Product Code
- MON FDA UDI
- GMDN Term
- Haemodialysis dialysate central supply system FDA UDI
Classification
- Device Class
- Class I 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemodialysis dialysate central supply system
Dialyzer Dialysate QD to 3/8 in.NPT by Reprocessing Products Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis dialysate central supply system.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Reprocessing Products Corp
Sources (1)
- FDA UDI 088dff46-8800-4313-a660-eef4172ede95 32 fields · synced May 29, 2026