UDI device identifier
ONE-LINK 7N8378
UDI device identifier 00085412091792 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412091792 |
|---|---|
| Brand name | ONE-LINK |
| Version or model | 7N8378 |
| Catalog number | 7N8378 |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | FPA |
| GMDN term | Intravenous administration tubing extension set |
| Premarket submission | K132734 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 24, 2016 |
| Version date | Jul 6, 2018 |
| Description | Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV Connector with Neutral Fluid Displacement, Male Luer Lock Adapter with Retractable Collar |
At a glance
- 10–99 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ 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: