SafeSheath CSG FCL-069-02/A

GUDID 10884450484347

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450484347
• NIH Device Record Key: 9e16cc30-309d-49c1-b13e-0fa6d7678ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSheath CSG
• Version Model Number: 00884450484340
• Catalog Number: FCL-069-02/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450484340 [Primary]
GS1	10884450484347 [Package]; Contains: 00884450484340; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120158

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [SafeSheath CSG]

• 10884450484385: 00884450484388
• 10884450484347: 00884450484340
• 10884450484354: 00884450484357
• 10884450484361: 00884450484364
• 10884450484330: 00884450484333
• 10884450484439: 00884450484432
• 10884450484422: 00884450484425
• 10884450484415: 00884450484418
• 10884450484408: 00884450484401
• 10884450484392: 00884450484395
• 10884450484323: 00884450484326