PhaSeal Optima

Basic Information

• Brand Name: PhaSeal Optima
• Primary DI: 00382905150630
• Version / Model: 515063
• Catalog Number: 515063
• Company Name: BECTON DICKINSON PEN LIMITED
• Labeler DUNS: 988402590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-29
• Public Version: 1
• Public Version Date: 2022-08-08
• Public Version Status: New
• Public Device Record Key: 201062d3-f595-4940-9c58-3499b7d4e9de

Device Description

PhaSeal Optima Protector (P28-O)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60537	Vial/bottle adaptor, hermetic	A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382905150631	GS1	Box	25	In Commercial Distribution
Primary	00382905150630	GS1
Package	50382905150635	GS1	Case	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]