FDA.reportPublic FDA data

Alaris, SmartSite

Primary DI
10885403234859
Brand
Alaris, SmartSite
Company
BD Switzerland Sàrl
Model
20027E
Catalog number
20027E
Device description
Extension Set 0.2 Micron Low Protein Binding Filter Needle-Free Valve
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
50885403234857PackageGS1100In Commercial Distribution
10885403234859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323485750885403234857
1088540323485910885403234859

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
Length18Inch

Storage And Handling#

Type, Low, High table
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 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
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
00382905150036BD PhaSeal5150035150032016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
00887709190207ICU Medical, Inc.ICU MEDICAL, INC.LHI2026-08-07
00887709190214ICU Medical, Inc.ICU MEDICAL, INC.LHI2026-08-07
18859299138111ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138128ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationLHI2026-06-30
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
10813153027384CodanCodan US CorporationLHI2026-06-25
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23