FDA.reportPublic FDA data

Alaris, SmartSite

Primary DI
10885403235016
Brand
Alaris, SmartSite
Company
BD Switzerland Sàrl
Model
22059E
Catalog number
22059E
Device description
Extension Set, Needle-free Valve (detachable), 23 cm (9 in)
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular
LHISet, i.V. Fluid transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403235014PackageGS1100In Commercial Distribution
10885403235016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323501450885403235014
1088540323501610885403235016

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433customer_support@bd.com

Regulatory Flags#

DUNS number
482631558
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403237898Tru-SecureTS1000TS10002016-10-17
00382903949106Connecta, Luer-Lok3949103949102023-09-21
00382905156298BD PhaSeal Optima5156295156292026-01-09
30382905156299BD PhaSeal Optima5156295156292026-01-09
00382905156281BD PhaSeal Optima5156285156282025-12-19
30382905156282BD PhaSeal Optima5156285156282025-12-19
10885403235610AlarisC25012C250122016-09-22
07613203010931Alaris, SmartSite42290E42290E2016-10-17
07613203010962Alaris, SmartSite42273E42273E2016-09-22
10885403222610AlarisMS3500-15MS3500-152016-09-22
10885403234859Alaris, SmartSite20027E20027E2016-09-22
10885403235306Alaris, SmartSite41177E41177E2016-09-22
10885403274220Alaris, SmartSite41176E41176E2016-09-22
10885403230110Alaris10016073100160732016-09-22
07613203010917Alaris, SmartSite42293E42293E2016-09-22
10885403236532BD MaxPlusMP2000MP20002016-09-22
10885403236778BD MaxPlusMP9004MP90042016-09-22
10885403236990BD MaxPlusMP9218-CMP9218-C2016-09-22
10885403302060Alaris, SmartSiteMPC-02MPC-022016-09-22
00382905150012BD PhaSeal5150015150012016-09-19

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10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
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