BD Ultra-Fine Insulin Syringes, 3/10mL x 8MM Mail Order 328291

GUDID 50382903282918

SYRINGE 0.3ML 8MM 90 BX 450 MO

Becton, Dickinson and Company Inc

Insulin syringe/needle, basic

• Primary Device ID: 50382903282918
• NIH Device Record Key: 0d8da1fb-9536-4811-aa9c-5adc5af33159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Ultra-Fine Insulin Syringes, 3/10mL x 8MM Mail Order
• Version Model Number: 328291
• Catalog Number: 328291
• Company DUNS: 047047543
• Company Name: Becton, Dickinson and Company Inc
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Total Volume: 0.3 Milliliter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Total Volume: 0.3 Milliliter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Total Volume: 0.3 Milliliter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Total Volume: 0.3 Milliliter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903282913 [Primary]
GS1	00382903664306 [Unit of Use]
GS1	30382903282914 [Primary]
GS1	50382903282918 [Package]; Contains: 00382903282913; Package: Case [5 Units]; In Commercial Distribution
GS1	80382903282919 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024112

FDA Product Code

• FMF: Syringe, piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

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