FDA.reportPublic FDA data

Alaris, SmartSite

Primary DI
10885403302060
Brand
Alaris, SmartSite
Company
BD Switzerland Sàrl
Model
MPC-02
Catalog number
MPC-02
Device description
Safety Cap
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
20885403302067PackageGS1100In Commercial Distribution
50885403302068PackageGS124In Commercial Distribution
10885403302060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540330206720885403302067
5088540330206850885403302068
1088540330206010885403302060

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure intravenous line needleless valve-connectorA 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.

Storage And Handling#

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

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
00382905150012BD PhaSeal5150015150012016-09-19
00382905150036BD PhaSeal5150035150032016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840000014VYGONVygon CorporationFPA2017-07-28
08498840001172VYGONVygon CorporationFPA2017-07-05
08426314583527FLEBOSETLABORATORIOS GRIFOLS SALHI2017-04-05
08426314734561QUICKPINLABORATORIOS GRIFOLS SALHI2017-04-05
08426314792578FLEBOSETLABORATORIOS GRIFOLS SALHI2017-04-05
08426314601146SET GRI-FILL 3.0LABORATORIOS GRIFOLS SALHI2017-01-02
08426314601153SET GRI-FILL 3.0LABORATORIOS GRIFOLS SALHI2017-01-02
08426314601160SET GRI-FILL 3.0LABORATORIOS GRIFOLS SALHI2017-01-02
08436020760563DOSI-FLOWLEVENTON SAUFPA2016-11-30
08436020761362DOSI-FLOWLEVENTON SAUFPA2016-11-30
08436020761706DOSI-FLOWLEVENTON SAUFPA2016-11-30
08436020763465DOSI-FLOWLEVENTON SAUFPA2016-11-30
08436020764257DOSI-FLOWLEVENTON SAUFPA2016-11-30
07613203009874Alaris, Signature Edition, SmartSiteBD Switzerland SàrlFPA2016-10-17
07613203010894Alaris, SmartSiteBD Switzerland SàrlLHI2016-10-17
07613203011495Alaris, SmartSiteBD Switzerland SàrlLHI2016-10-17
07613117010386Soft-Release-OYpsomed AGFPA2016-09-24
07613117010409Soft-Release-OYpsomed AGFPA2016-09-24
07613117010447Soft-Release-OYpsomed AGFPA2016-09-24
07613117010461Soft-Release-OYpsomed AGFPA2016-09-24
07613117010485Soft-Release-OYpsomed AGFPA2016-09-24