Merit H2O™ H2OSTDA35180/A

GUDID 10884450056179

Merit Medical Systems, Inc.

Peripheral vascular guidewire, manual

Primary Device ID	10884450056179
NIH Device Record Key	931bfef9-4a60-470d-8ca3-4024a93869aa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Merit H2O™
Version Model Number	00884450056172
Catalog Number	H2OSTDA35180/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	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	00884450056172 [Primary]
GS1	10884450056179 [Package] Contains: 00884450056172 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K000011

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	2016-10-11

On-Brand Devices [Merit H2O™]

00884450110904	00884450110904
10884450057107	00884450057100
10884450057091	00884450057094
10884450056957	00884450056950
10884450056940	00884450056943
10884450056728	00884450056721
10884450056711	00884450056714
10884450056704	00884450056707
10884450056698	00884450056691
10884450056681	00884450056684
10884450056674	00884450056677
10884450056247	00884450056240
10884450056230	00884450056233
10884450056223	00884450056226
10884450056216	00884450056219
00884450056202	00884450056202
10884450056193	00884450056196
10884450056186	00884450056189
10884450056179	00884450056172
10884450056162	00884450056165
10884450056155	00884450056158
10884450056148	00884450056141

Trademark Results [Merit H2O]

Mark Image Registration \| Serial	Company Trademark Application Date
MERIT H2O 78686352 3203573 Live/Registered	Merit Medical Systems, Inc. 2005-08-05