FDA.report

Alaris, SmartSite

Primary DI
07613203010931
Brand
Alaris, SmartSite
Company
BD Switzerland Sàrl
Model
42290E
Catalog number
42290E
Device description
Gravity Set Check Valve, 2 Needle-Free Valves, Nonvented 265 cm (104 in)
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FPASet, administration, intravascular
LHISet, i.V. Fluid transfer

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613203010949PackageGS1100In Commercial Distribution
07613203010931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761320301094937613203010949
07613203010931076132030109317613203010931

GMDN Terms

TermDefinition
Basic intravenous administration set, noninvasiveA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length104Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)823-5433customer_support@bd.com

Regulatory Flags

DUNS number
482631558
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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