Identifiers
- 510(k) Number
- K110703 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD AutoShield Duo Pen Needle is a safety pen needle designed for insulin administration, featuring dual front and back-end shields to enhance convenience and safety before and after injection. It falls under the category of disposable pen needles, combining functionality with user protection to reduce the risk of needle-stick injuries.
This device is supplied as a single-use, sterile product and is intended for use in clinical settings such as general nursing and insulin management. The needle gauge is 30, with a length of 5mm (3/16 inch), and is packaged in boxes of 100 needles, with 8 boxes per case. The device holds an FDA 510(k) clearance under the product code FMI, classified as substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD AutoShield™ Duo Pen Needle Now Available through Retail Pharmacies ..., BD AutoShield Duo Safety Pen Needle 30g x 3/16" 5mm, AutoShield™ Duo Insulin Pen Needle, 30ga, 5mm Long
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110703 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K110703 24 fields · synced Sep 18, 2026