Sonostik Single Port ClearSafe Comfort Catheter Not Applicable

GUDID 00840155413672

Single Port ClearSafe Comfort, Closed Catheter 20G x 1”

MEDSOURCE INTERNATIONAL LLC

Central venous catheter inside-out introduction set

• Primary Device ID: 00840155413672
• NIH Device Record Key: d4adba75-b460-4d4b-9a5c-3931b234154a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonostik Single Port ClearSafe Comfort Catheter
• Version Model Number: MS-872202
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840155413665 [Primary]
GS1	00840155413672 [Package]; Contains: 00840155413665; Package: Box [50 Units]; In Commercial Distribution
GS1	00840155413689 [Package]; Contains: 00840155413665; Package: Case [200 Units]; In Commercial Distribution

FDA Product Code

• DYB: Introducer, Catheter

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: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [Sonostik Single Port ClearSafe Comfort Catheter]

• 00840155413672: Single Port ClearSafe Comfort, Closed Catheter 20G x 1”
• 00840155413641: Single Port ClearSafe Comfort, Closed Catheter 14G x 1.25”