InQwire® Amplatz IQA501

GUDID 10884450239497

Merit Medical Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	10884450239497
NIH Device Record Key	17db0ae1-6970-41a5-8c84-a70150010442
Commercial Distribution Status	In Commercial Distribution
Brand Name	InQwire® Amplatz
Version Model Number	00884450239490
Catalog Number	IQA501
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	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	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450239490 [Primary]
GS1	10884450239497 [Package] Contains: 00884450239490 Package: [5 Units] In Commercial Distribution
GS1	20884450239494 [Package] Package: [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170700

FDA Product Code

DQX	WIRE, GUIDE, 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	2018-07-06
Device Publish Date	2017-05-11

On-Brand Devices [InQwire® Amplatz]

10884450355968	00884450355961
20884450355958	00884450355954
10884450335977	00884450335970
20884450311510	00884450311516
20884450311497	00884450311493
10884450239800	00884450239803
10884450239794	00884450239797
10884450239787	00884450239780
10884450239770	00884450239773
20884450239760	00884450239766
20884450239753	00884450239759
10884450239749	00884450239742
20884450239739	00884450239735
10884450239718	00884450239711
10884450239701	00884450239704
10884450239695	00884450239698
20884450239685	00884450239681
10884450239671	00884450239674
20884450239661	00884450239667
10884450239503	00884450239506
10884450239497	00884450239490
10884450239473	00884450239476
20884450239463	00884450239469
20884450239456	00884450239452
10884450434632	00884450434635
20884450434622	00884450434628
20884450434646	00884450434642

Trademark Results [InQwire]

Mark Image Registration \| Serial	Company Trademark Application Date
INQWIRE 86803978 5092667 Live/Registered	Nephew, Jill 2015-10-29
INQWIRE 85794963 not registered Dead/Abandoned	AROUNDWIRE, LLC 2012-12-05
INQWIRE 75356437 2494586 Live/Registered	Merit Medical Systems, Inc. 1997-08-22
INQWIRE 75356352 2494585 Live/Registered	Merit Medical Systems, Inc. 1997-08-22