BD Ultra-Fine Pen Needles, 29G x 12MM Mail Order 320880

GUDID 50382903208802

PEN NDL 29G 12.7MM 90 COUNT MAIL ORDER

BECTON DICKINSON PEN LIMITED

Autoinjector needle

• Primary Device ID: 50382903208802
• NIH Device Record Key: 31faaaef-ce99-472b-893b-5515647ced51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Ultra-Fine Pen Needles, 29G x 12MM Mail Order
• Version Model Number: 320880
• Catalog Number: 320880
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• Device Count: 90
• 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

• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12.7 Millimeter
• Needle Gauge: 29 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382900880099 [Unit of Use]
GS1	00382903208807 [Primary]
GS1	50382903208802 [Package]; Contains: 00382903208807; Package: Case [12 Units]; In Commercial Distribution
GS1	80382903208803 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131358
• Premarket Notification: K213478

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: 2016-08-03

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• 30382905153021 - BD PhaSeal: 2023-05-18 Secondary Set (C61)
• 30382905154066 - BD PhaSeal: 2023-05-18 Connector Cap (M70)