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FDA UDI In Commercial Distribution 🇺🇸 United States

Alaris, SmartSite

DI: 07613203010917 · Model: 42293E · BD Switzerland Sàrl

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Product Codes

2

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Alaris, SmartSite
Primary DI: 07613203010917
Version / Model: 42293E
Catalog Number: 42293E
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: 10
Public Version Date: 2025-12-16
Public Version Status: Update
Public Device Record Key: ac26ec31-aa8d-490b-ae92-5d0d4b285ee3

Device Description

Gravity Set Check Valve 2 Needle-Free Valves Vented/Nonvented

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
LHI	Set, i.V. Fluid transfer	General Hospital	880.5440	2
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	07613203010917	GS1

Customer Contacts

Phone: +1(844)823-5433
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	104	Inch

Storage Conditions

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