FDA.reportPublic FDA data

TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site

Primary DI
27298119121168
Brand
TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site
Company
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Model
MG412116
Catalog number
MG412116
Device description
TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site 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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141306000TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITETeva Medical Ltd., Migada Plant2014-06-12FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27298119121168PrimaryGS10
07298119121164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729811912116827298119121168
07298119121164072981191211647298119121164

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600029649
Device count
100
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
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
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

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