ProSeal CSTD

GUDID 38859299133509

ProSeal Closed System Administration Set

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Basic intravenous administration set, noninvasive
Primary Device ID38859299133509
NIH Device Record Keyf198c87c-184a-4f29-994a-b7e1d4117316
Commercial Distribution StatusIn Commercial Distribution
Brand NameProSeal CSTD
Version Model Number423500
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
GS118859299133505 [Primary]
GS138859299133509 [Package]
Contains: 18859299133505
Package: Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

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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