Dial Ease FCL-182-00

GUDID 10884450258191

Merit Medical

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Primary Device ID	10884450258191
NIH Device Record Key	ce4806bb-5a09-43b1-85c0-890af0556e43
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dial Ease
Version Model Number	00884450258194
Catalog Number	FCL-182-00
Company DUNS	065673912
Company Name	Merit Medical
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450258194 [Primary]
GS1	10884450258191 [Package] Contains: 00884450258194 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K043438

FDA Product Code

DYB	INTRODUCER, CATHETER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-06-07
Device Publish Date	2018-03-07

Devices Manufactured by Merit Medical

00884450313763 - Prelude Prestige™	2024-03-20
00884450313794 - Prelude Prestige™	2024-03-20
00884450495568 - Hydrophilic Prelude SNAP™	2021-11-30
00884450313732 - Prelude Prestige™	2021-10-11
00884450313800 - Prelude Prestige™	2021-10-11
00884450313831 - Prelude Prestige™	2021-10-11
00884450313855 - Prelude Prestige™	2021-10-11
00884450451410 - HeartSpan®	2021-01-01

Trademark Results [Dial Ease]

Mark Image Registration \| Serial	Company Trademark Application Date
DIAL EASE 86016078 not registered Dead/Abandoned	Merit Medical Systems, Inc. 2013-07-22
DIAL EASE 78682681 3210355 Dead/Cancelled	Merit Medical Systems, Inc. 2005-08-01