TEVADAPTOR® Syringe Adaptor

Primary DI
27298119121182
Brand
TEVADAPTOR® Syringe Adaptor
Company
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Model
MG412118
Catalog number
MG412118
Device description
TEVADAPTOR® Syringe Adaptor HF 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
Rx
false
OTC
true
Sterile
false
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
27298119121182PackageGS16In Commercial Distribution
17298119121185PrimaryGS10
07298119121188Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729811912118227298119121182
1729811912118517298119121185
07298119121188072981191211887298119121188

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600029649
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
17298119121116TEVADAPTOR® Vial Adaptor MG412111MG4121112016-09-15
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
27298119121199TEVADAPTOR® 28mm Vial AdaptorMG412119 MG412119 2016-09-15
27298119121120TEVADAPTOR® Connecting SetMG412112MG4121122016-09-15
27298119121137TEVADAPTOR® Spike Port AdaptorMG412113MG4121132016-09-15

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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
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