BIOSITE/BIOSITE PLUS

Basic Information

• Brand Name: BIOSITE/BIOSITE PLUS
• Primary DI: B134JR025AU2
• Version / Model: JR-025-AU
• Catalog Number: JR-025-AU
• Company Name: MACLIN POWER, INC.
• Labeler DUNS: 962650714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-02-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cbd24807-9bee-4953-8ea7-1341ca2204e0

Device Description

JR-025-AU Biosite with Flow Control

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: 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: 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B134JR025AU2	HIBCC
Unit of Use	B134JR025AU0	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.