ProSeal CSTD

Basic Information

• Brand Name: ProSeal CSTD
• Primary DI: 18859299124145
• Version / Model: 423850VT
• Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
• Labeler DUNS: 662213220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-11
• Public Version: 2
• Public Version Date: 2025-09-29
• Public Version Status: Update
• Public Device Record Key: be418296-7110-413c-a60f-6d5e0b3a7ab0

Device Description

ProSeal Inline Pump Set (DMA Compatible)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38859299124149	GS1	Carton	200	In Commercial Distribution
Primary	18859299124145	GS1

Premarket Submissions

Submission Number	Supplement Number
K241735	000