FDA.reportPublic FDA data

OnGuard2 Chemfort Closed Y Inline Set

Primary DI
37290115921671
Brand
OnGuard2 Chemfort Closed Y Inline Set
Company
SIMPLIVIA HEALTHCARE LTD
Model
412167
Device description
For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Y Inline Set connects to Bag Adaptor CP and to a primary set
Published
2021-10-17
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
K210707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210707000OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare , Ltd.2021-09-23ONB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37290115921671PrimaryGS10
17290115921677Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3729011592167137290115921671
1729011592167717290115921677

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.

Contacts#

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

Regulatory Flags#

DUNS number
521161349
Device count
70
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
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