ClariVein® IC 85-018-E140S/B

GUDID 00884450429242

Merit Medical Systems, Inc.

Peripheral vascular infusion catheter

• Primary Device ID: 00884450429242
• NIH Device Record Key: 39e4bc4e-29c0-47fd-a193-7bc4f5058584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariVein® IC
• Version Model Number: 10884450429249
• Catalog Number: 85-018-E140S/B
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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: true
• 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	00884450429242 [Unit of Use]
GS1	10884450429249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153502

FDA Product Code

• KRA: Catheter, continuous flush

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: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [ClariVein® IC]

• 10884450412821: 10884450412821
• 10884450412814: 10884450412814
• 10884450412838: 10884450412838
• 10884450429263: 10884450429263
• 00884450429280: 10884450429287
• 00884450429242: 10884450429249