UDI device identifier
MARK 5 NUVO 10 1005GC
UDI device identifier 00038214001599 · NIDEK MEDICAL PRODUCTS, INC.
Key facts
| Primary DI | 00038214001599 |
|---|---|
| Brand name | MARK 5 NUVO 10 |
| Version or model | 1005GC |
| Catalog number | 1005GC |
| Company | NIDEK MEDICAL PRODUCTS, INC. |
| DUNS number | 161382940 |
| Product code | CAW |
| GMDN term | Stationary oxygen concentrator |
| Premarket submission | K123738 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Aug 24, 2016 |
| Version date | Jul 6, 2018 |
| Description | 230V OCSI 10LPM OXYGEN CONCENTRATOR -- PRIVATE LABELED FOR GCE MEDILINE |
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: