BD PhaSeal Optima 515628

GUDID 30382905156282

BD Phaseal™ Optima Spike Set (C180-O)

BD Switzerland Sàrl

Non-ISO80369 formatted bag access spike

• Primary Device ID: 30382905156282
• NIH Device Record Key: d695dea4-30a9-4be0-abbd-06d91c741840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD PhaSeal Optima
• Version Model Number: 515628
• Catalog Number: 515628
• Company DUNS: 482631558
• Company Name: BD Switzerland Sàrl
• 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

Customer Support Contacts

• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382905156281 [Primary]
GS1	30382905156282 [Package]; Contains: 00382905156281; Package: Pack or Inner Pack [50 Units]; In Commercial Distribution
GS1	50382905156286 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250059

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [BD PhaSeal Optima]

• 30382905156282: BD Phaseal™ Optima Spike Set (C180-O)
• 30382905156299: BD Phaseal™ Optima Connecting Set (C83-O)