FDA.reportPublic FDA data

TEVADAPTOR® Vial Adaptor

Primary DI
17298119121116
Brand
TEVADAPTOR® Vial Adaptor
Company
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Model
MG412111
Catalog number
MG412111
Device description
TEVADAPTOR® 20 mm Vial Adaptor and 13mm converter for use with OnGuardTM contained Medication System
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141448000TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEMTeva Medical Ltd., Migada Plant2015-01-23ONB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27298119121113PackageGS14In Commercial Distribution
17298119121116PrimaryGS10
07298119121119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729811912111327298119121113
1729811912111617298119121116
07298119121119072981191211197298119121119

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Regulatory Flags#

DUNS number
600029649
Device count
50
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
27298119121151TEVADAPTOR® Connecting Set with ULTRASITE® Injection SiteMG412115MG412115 2016-09-15
27298119121168TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection SiteMG412116MG4121162016-09-15
27298119121205TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. SiteMG412120MG412120 2016-09-15
17298119121147TEVADAPTOR® Luer Lock AdaptorMG412114MG4121142016-09-15
17298119121185TEVADAPTOR® Syringe Adaptor MG412118MG4121182016-09-15
17298119121192TEVADAPTOR® 28mm Vial AdaptorMG412119MG4121192016-09-15
27298119121113TEVADAPTOR® Vial Adaptor MG412111 MG412111 2016-09-15
27298119121144TEVADAPTOR® Luer Lock AdaptorMG412114 MG412114 2016-09-15
27298119121182TEVADAPTOR® Syringe Adaptor MG412118 MG412118 2016-09-15
27298119121199TEVADAPTOR® 28mm Vial AdaptorMG412119 MG412119 2016-09-15
27298119121120TEVADAPTOR® Connecting SetMG412112MG4121122016-09-15
27298119121137TEVADAPTOR® Spike Port AdaptorMG412113MG4121132016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840619023720ICU MedicalICU MEDICAL, INC.ONB2023-06-02
00382905150708BD PhaSeal OptimaBD Switzerland SàrlONB2023-05-10
00382905153020BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905154065BD PhaSealBD Switzerland SàrlONB2023-05-10
00382905150784BD PhaSeal OptimaBD Switzerland SàrlONB2023-04-26