Alaris, SmartSite

Basic Information

• Brand Name: Alaris, SmartSite
• Primary DI: 07613203012751
• Version / Model: 2000EA
• Catalog Number: 2000EA
• 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: 7
• Public Version Date: 2025-07-31
• Public Version Status: Update
• Public Device Record Key: 74c0a421-c4e0-4067-91f8-167e3eb7d749

Device Description

Needle-Free Valve

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
LHI	Set, i.V. Fluid transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42743	Negative-pressure intravenous line needleless valve-connector	A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613203012769	GS1	Case	2	In Commercial Distribution
Primary	07613203012751	GS1
Package	27613203021689	GS1	Box	50	In Commercial Distribution
Secondary	H3702000EA19	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size = Priming Volume = 0.1 millilitre (mL)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -40 – 125 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care