FDA.reportPublic FDA data

BD PhaSeal

Primary DI
00382905150043
Brand
BD PhaSeal
Company
BD Switzerland Sàrl
Model
515004
Catalog number
515004
Device description
Injector Luer Lock (N35C)
Published
2016-09-19
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
ONBClosed antineoplastic and hazardous drug reconstitution and transfer system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382905150044PackageGS150In Commercial Distribution
50382905150048PackageGS14In Commercial Distribution
00382905150043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290515004430382905150044
5038290515004850382905150048
00382905150043003829051500433829051500430382905150043

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
482631558
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403520631BD Alaris Pump Infusion Set3881633881632026-10-09
10885403533839BD Alaris Pump Infusion Set3883653883652026-10-09
10885403533846BD Alaris Pump Infusion Set3883643883642026-10-09
07613203011778SmartSite2205E2205E2016-09-22
10885403232329Alaris, SmartSite2432-00072432-00072016-09-22
10885403232558Alaris, SmartSite11426965114269652016-09-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
1885929912157113 mm Vial ConverterEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-10-20
18859299130733ToxiSeal Vial Adaptor with External Flip BalloonEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-09-04
18859299121533ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
18859299121540ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
18859299121557ProSeal Transfer InjectorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-08-07
00850031983038Zephyrus InnovationsVAULT PARAGON GROUP, INC.ONB2026-05-21
18859299131013ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
18859299131051ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
18859299133857ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2026-03-11
00382905156298BD PhaSeal OptimaBD Switzerland SàrlONB2026-01-09
00382905156281BD PhaSeal OptimaBD Switzerland SàrlONB2025-12-19
18859299119950ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124114ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124121ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124138ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124145ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299124152ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130696ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130702ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
18859299130719ProSeal CSTDEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDONB2025-09-11
27290115921858OnGuard2 Female Luer Lock AdaptorSIMPLIVIA HEALTHCARE LTDONB2025-08-17
27290115921711OnGuard®2 20mm Vial Adaptor II and 13mm convertorSIMPLIVIA HEALTHCARE LTDONB2024-09-15
27290115921759OnGuard2 20mm Vial Adaptor, 10 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921872OnGuard2 20mm Vial Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921889OnGuard2 Syringe Adaptor, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921896OnGuard2 Syringe Adaptor Lock II, 5 UnitsSIMPLIVIA HEALTHCARE LTDONB2024-09-08
27290115921865OnGuard2 Bag Adaptor SP IISIMPLIVIA HEALTHCARE LTDONB2024-05-06
27290115921827OnGaurd2 CSTD Catheter Adaptor SIMPLIVIA HEALTHCARE LTDONB2023-09-12
10885403470127MaxZeroBD Switzerland SàrlONB2023-07-27
00382905153013BD PhaSealBECTON DICKINSON PEN LIMITEDONB2023-07-27