UDI device identifier
Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's 272830
UDI device identifier 00015482272838 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482272838 |
|---|---|
| Brand name | Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's |
| Version or model | 272830 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | FMI |
| GMDN term | Autoinjector needle |
| Premarket submission | K191853 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Jan 21, 2020 |
| Version date | Aug 24, 2026 |
| Description | Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the… |
At a glance
- None 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: