UDI device identifier
MedicaLyte BC+201
UDI device identifier 00817411022824 · NIPRO RENAL SOLUTIONS USA CORPORATION
Key facts
| Primary DI | 00817411022824 |
|---|---|
| Brand name | MedicaLyte |
| Version or model | BC+201 |
| Company | NIPRO RENAL SOLUTIONS USA CORPORATION |
| DUNS number | 117439434 |
| Product code | KPO |
| GMDN term | Haemodialysis concentrate |
| Premarket submission | K012547 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 29, 2020 |
| Version date | Oct 7, 2020 |
| Description | Liquid Bicarbonate Concentrate for Hemodialysis |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: