BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM 328468

GUDID 50382903284684

SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

Becton, Dickinson and Company Inc

Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: 50382903284684
• NIH Device Record Key: 4851e2af-2896-4049-bed4-ad69c4b2dd5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM
• Version Model Number: 328468
• Catalog Number: 328468
• 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

• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903666683 [Unit of Use]
GS1	00382908468039 [Primary]
GS1	50382903284684 [Package]; Contains: 00382908468039; Package: Case [5 Units]; In Commercial Distribution

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

On-Brand Devices [BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM]

• 50382903284684: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• 50382903267304: SYRINGE 0.5ML 31GA 6MM U500 10BAG 500CS