Alaris, SmartSite

Basic Information

• Brand Name: Alaris, SmartSite
• Primary DI: 07613203009577
• Version / Model: 82115E
• Catalog Number: 82115E
• Company Name: BD Switzerland Sàrl
• Labeler DUNS: 482631558
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: fff4eee7-4287-45ac-a4d5-78a8f8429c4d

Device Description

Add-On Burette Set, Ball Valve Drip Chamber Needle-Free Valve (Burette) Vented/NoVented 64 cm (25 in)

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
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613203009577	GS1
Package	37613203009585	GS1	Case	20	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	25	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 125 Degrees Fahrenheit