ClariVein® IC 45-018-E2S/A

GUDID 10884450412838

Merit Medical Systems, Inc.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

Primary Device ID	10884450412838
NIH Device Record Key	6f2ad818-6499-47ef-8900-02f2ce1f93b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	ClariVein® IC
Version Model Number	10884450412838
Catalog Number	45-018-E2S/A
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450412831 [Unit of Use]
GS1	10884450412838 [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	2019-10-10
Device Publish Date	2019-10-02

On-Brand Devices [ClariVein® IC]

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

Trademark Results [ClariVein]

Mark Image Registration \| Serial	Company Trademark Application Date
CLARIVEIN 77552610 3733262 Live/Registered	Vascular Insights LLC 2008-08-21