BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O) 515057

GUDID 50382905150574

INJECTOR LOCKING N40-O MULTI

BECTON DICKINSON PEN LIMITED

Luer/non-ISO80369-standardized linear connector, single-use

• Primary Device ID: 50382905150574
• NIH Device Record Key: 8fd1b425-5d42-436b-bfb2-d92f93808413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O)
• Version Model Number: 515057
• Catalog Number: 515057
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382905150579 [Primary]
GS1	30382905150570 [Package]; Contains: 00382905150579; Package: Box [250 Units]; In Commercial Distribution
GS1	50382905150574 [Package]; Contains: 00382905150579; Package: Case [250 Units]; In Commercial Distribution

FDA Product Code

• ONB: Closed antineoplastic and hazardous drug reconstitution and transfer system

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: 2021-04-22
• Device Publish Date: 2021-04-14

On-Brand Devices [BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O)]

• 50382905150574: INJECTOR LOCKING N40-O MULTI
• 30382905150563: INJECTOR LOCKING N40-O