FDA.reportPublic FDA data

ProSeal CSTD

Primary DI
38859299130690
Brand
ProSeal CSTD
Company
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Model
420690
Device description
ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 13 mm Vial
Published
2025-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
K241476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241476000ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte. , Ltd.2024-06-21ONB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38859299130690PackageGS180In Commercial Distribution
18859299130696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3885929913069038859299130690
1885929913069618859299130696

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, hermeticA device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
662213220
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1885929912157113 mm Vial Converter423470RX2026-10-20
18859299151073SMARTeZ RS475160U2026-10-06
18859299150984SMARTeZ RS475070U2026-09-23
18859299151080SMARTeZ RS475170U2026-09-23
18859299151097SMARTeZ RS475180U2026-09-23
18859299151103SMARTeZ RS475190U2026-09-23
18859299130733ToxiSeal Vial Adaptor with External Flip Balloon4207302026-09-04
18859299175079SMARTeZ RS4750702026-09-04
18859299175178SMARTeZ RS4751702026-09-04
18859299175185SMARTeZ RS4751802026-09-04
18859299175192SMARTeZ RS4751902026-09-04
18859299121533ProSeal Transfer Injector421120RX2026-08-07
18859299121540ProSeal Transfer Injector421130RX2026-08-07
18859299121557ProSeal Transfer Injector421140RX2026-08-07
18859299138111ADRx Admixture System4281102026-08-01
18859299138128ADRx Admixture System4281202026-08-01
18859299138326ADRx Admixture System4283202026-08-01
18859299123612eZSURE™426030SF2026-04-10
18859299123629eZSURE™426040SF2026-04-10
18859299123636eZSURE™426110SF2026-04-10

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