SURECAN SAFETY II

Basic Information

• Brand Name: SURECAN SAFETY II
• Primary DI: 04046964858130
• Version / Model: 4447010-02
• Catalog Number: 4447010-02
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-12-07
• Public Version: 3
• Public Version Date: 2020-03-03
• Public Version Status: Update
• Public Device Record Key: eb276f29-8af0-483b-9054-efb56c012830

Device Description

Surecan™ Safety II Port Access Needle Set 22G x 0.6in. (15mm)

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PTI	Non-Coring (Huber) Needle	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04046964999918	GS1	Carton	5	In Commercial Distribution
Primary	04046964858130	GS1
Unit of Use	04046964858123	GS1

Customer Contacts

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