ProSeal CSTD

GUDID 38859299124132

ProSeal Injector Plus (DMA Compatible)

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Luer/Luer linear connector, single-use
Primary Device ID38859299124132
NIH Device Record Key7f5867d9-8f0d-4ab5-9bf5-12d5d1f49a3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameProSeal CSTD
Version Model Number421050VT
Company DUNS662213220
Company NameEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118859299124138 [Primary]
GS138859299124132 [Package]
Contains: 18859299124138
Package: Carton [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-19
Device Publish Date2025-09-11

On-Brand Devices [ProSeal CSTD]

38859299133509ProSeal Closed System Administration Set
38859299130713ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 28 mm Vial
38859299130706ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial
38859299130690ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 13 mm Vial
38859299124156ProSeal Injection Site -Extended MLL (DMA Compatible)
38859299124149ProSeal Inline Pump Set (DMA Compatible)
38859299124132ProSeal Injector Plus (DMA Compatible)
38859299124125ProSeal Injector (DMA Compatible)
38859299124118ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)
38859299119954ProSeal Spike with Additive Port and Seal Tab (DMA Compatible)

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