Pen Needles, 31G x 8MM 320981

GUDID 50382903209816

PEN NDL 31G 8MM 100 BX 1200 PL

BECTON DICKINSON PEN LIMITED

Autoinjector needle

• Primary Device ID: 50382903209816
• NIH Device Record Key: 56b2b66f-72ea-45ef-8fd1-f355a2ef7a95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pen Needles, 31G x 8MM
• Version Model Number: 320981
• Catalog Number: 320981
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• 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

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382900981093 [Unit of Use]
GS1	00382903209811 [Primary]
GS1	50382903209816 [Package]; Contains: 00382903209811; Package: Case [12 Units]; In Commercial Distribution
GS1	80382903209817 [Unit of Use]

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: 2016-11-08

Devices Manufactured by BECTON DICKINSON PEN LIMITED

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• 50382905154039 - BD PhaSeal: 2023-09-25 Infusion Clamp (M25)
• 50382905153018 - BD PhaSeal: 2023-08-04 Secondary Set, Drip Chamber (C60)
• 50382905150703 - BD PhaSeal Optima: 2023-05-18 Connector (C35-O)
• 30382905153021 - BD PhaSeal: 2023-05-18 Secondary Set (C61)
• 30382905154066 - BD PhaSeal: 2023-05-18 Connector Cap (M70)