Identity
- Trade Name
- NIPRO ELISIO™ -M HEMODIALYZER FDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
- Device Name
- Surface area 2.1m² Max.TMP:66kPa(500mmHg) FDA UDI
- Model / Reference
- ELISIO™-21M FDA UDI
- Description
- Surface area 2.1m² Max.TMP:66kPa(500mmHg) FDA UDI
Identifiers
- Catalog Number
- DD+ELISIO-21M FDA UDI
- Primary DI / UDI-DI
- 00383790008532 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Hollow-fibre haemodialysis dialyser, single-use 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
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
Category: Hollow-fibre haemodialysis dialyser, single-use
Nipro Elisio™ -m Hemodialyzer by Nipro Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Nipro Medical Corporation
Sources (1)
- FDA UDI 2ae06d80-b8f6-4f8f-abe9-8ae8c49c133c 34 fields · synced Jun 1, 2026