ProSeal CSTD

GUDID 38859299124118

ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Non-ISO80369 formatted bag access spike

• Primary Device ID: 38859299124118
• NIH Device Record Key: 237fe9ac-7466-4479-8c0b-9cccb9ef1dad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSeal CSTD
• Version Model Number: 423840STWH
• Company DUNS: 662213220
• Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18859299124114 [Primary]
GS1	38859299124118 [Package]; Contains: 18859299124114; Package: Carton [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241988

FDA Product Code

• ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-19
• Device Publish Date: 2025-09-11

On-Brand Devices [ProSeal CSTD]

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