BD PhaSeal

Basic Information

• Brand Name: BD PhaSeal
• Primary DI: 30382905154035
• Version / Model: 515403
• Catalog Number: 515403
• Company Name: BECTON DICKINSON PEN LIMITED
• Labeler DUNS: 988402590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: 28667c0a-f4e5-4587-a6c7-75d5c1fea830

Device Description

Infusion Clamp (M25)

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMK	DEVICE, INTRAVASCULAR CATHETER SECUREMENT	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63390	Intravenous line closed infusion system clamp	A non-sterile device in the form of a closable housing intended to enclose and secure the connection (e.g., Luer connection) between mating components of a closed infusion system [e.g., closed system drug transfer device (CSTD)] attached to a patient’s IV line to help prevent inadvertent separation of the closed infusion system components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50382905154039	GS1	Case	4	In Commercial Distribution
Primary	30382905154035	GS1
Unit of Use	00382905154034	GS1

Customer Contacts

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