BD Nano 2nd Gen Pen Needle 320550

GUDID 50382903205504

PEN NDL 32G 4MM PRO 100 BOX 1200 US

BECTON DICKINSON PEN LIMITED

Autoinjector needle

• Primary Device ID: 50382903205504
• NIH Device Record Key: d6332ec2-d371-4ecc-a16a-75e4f00a4443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Nano 2nd Gen Pen Needle
• Version Model Number: 320550
• Catalog Number: 320550
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge

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	00382900550091 [Unit of Use]
GS1	00382903205509 [Primary]
GS1	50382903205504 [Package]; Contains: 00382903205509; Package: Case [12 Units]; In Commercial Distribution
GS1	80382903205505 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212015

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08

Devices Manufactured by BECTON DICKINSON PEN LIMITED

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• 50382905154053 - PhaSeal: 2023-11-28 Hanger for IV-bag (M55)
• 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)