BD Nano Ultra-Fine Pen Needles, 32G x 4MM 320540

GUDID 00382903205400

PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON

BECTON DICKINSON PEN LIMITED

Autoinjector needle

• Primary Device ID: 00382903205400
• NIH Device Record Key: 200aba8c-d656-40c9-87b2-41aaeba772cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Nano Ultra-Fine Pen Needles, 32G x 4MM
• Version Model Number: 320540
• Catalog Number: 320540
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• Device Count: 7
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038290054009 [Unit of Use]
GS1	00382903205400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131358

FDA Product Code

• FMI: Needle, hypodermic, single lumen

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: 2017-08-15

On-Brand Devices [BD Nano Ultra-Fine Pen Needles, 32G x 4MM]

• 00382903205400: PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON
• 50382903201223: PEN NDL 32G 4MM 100BX 1200 USA