AutoShield Duo 329515

GUDID 50383017951554

AutoShield Duo™ Pen Needles, 5mm, 30G, 3bevel, TW

Embecta Medical II, LLC

Autoinjector needle

• Primary Device ID: 50383017951554
• NIH Device Record Key: 8cf03cda-ed0d-4f96-a219-99a6fa5cf11a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoShield Duo
• Version Model Number: 329515
• Catalog Number: 329515
• Company DUNS: 118777356
• Company Name: Embecta Medical II, LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383017951535 [Primary]
GS1	50383017951554 [Package]; Contains: 00383017951535; Package: Case [8 Units]; In Commercial Distribution
GS1	80383017951586 [Unit of Use]

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-02
• Device Publish Date: 2024-11-22

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