FDA.reportPublic FDA data

OnGuard Spike Port Adaptor

Primary DI
37290115921138
Brand
OnGuard Spike Port Adaptor
Company
SIMPLIVIA HEALTHCARE LTD
Model
412113
Device description
The Spike Port Adaptor is part of the OnGuard CSTD system.The devices spike connects to IV solution container.The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug.
Published
2022-10-03
Public version status
New
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

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
37290115921138PrimaryGS10
17290115921134Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3729011592113837290115921138
1729011592113417290115921134

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

Contacts#

Phone, Email table
PhoneEmail
+97246909710customer.service@simplivia.com

Regulatory Flags#

DUNS number
521161349
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
27290115921612OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor4121612020-07-09
27290115921643OnGuard®2 CSTD Syringe Adaptor Lock4121642020-07-12
37290115921237Tevadaptor Catheter Adaptor 4121232021-02-18
37290115921817Catheter Adaptor MG4121812022-07-04
27290115921858OnGuard2 Female Luer Lock Adaptor4121852025-08-17
37290115921855OnGuard2 Female Luer Lock Adaptor4121852025-08-17
27290115921711OnGuard®2 20mm Vial Adaptor II and 13mm convertor4121712024-09-15
17290115921714OnGuard®2 20mm Vial Adaptor II and 13mm convertor4121712024-09-15
27290115921759OnGuard2 20mm Vial Adaptor, 10 Units4121752024-09-08
27290115921872OnGuard2 20mm Vial Adaptor, 5 Units4121872024-09-08
27290115921889OnGuard2 Syringe Adaptor, 5 Units4121882024-09-08
27290115921896OnGuard2 Syringe Adaptor Lock II, 5 Units4121892024-09-08
37290115921756OnGuard2 20mm Vial Adaptor, 10 Units4121752024-09-08
37290115921879OnGuard2 20mm Vial Adaptor, 5 Units4121872024-09-08
37290115921886OnGuard2 Syringe Adaptor, 5 Units4121882024-09-08
37290115921893OnGuard2 Syringe Adaptor Lock II, 5 Units4121892024-09-08
27290115921865OnGuard2 Bag Adaptor SP II4121862024-05-06
17290115921868OnGuard2 Bag Adaptor SP II4121862024-05-06
27290115921148OnGuard Luer Lock Adaptor 4121142022-10-03
37290115921213Tevadaptor Secondary IV Administration Set4121212021-02-18

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