Merit SwiftNINJA® MIV-20500/A

GUDID 00884450278505

Merit Medical Systems, Inc.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

Primary Device ID	00884450278505
NIH Device Record Key	997c73d5-78c8-491d-ab0a-701714dd6e70
Commercial Distribution Status	In Commercial Distribution
Brand Name	Merit SwiftNINJA®
Version Model Number	00884450278505
Catalog Number	MIV-20500/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	00884450278505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161921

FDA Product Code

KRA	Catheter, continuous flush

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-03-21
Device Publish Date	2016-12-07

On-Brand Devices [Merit SwiftNINJA®]

00884450323878	00884450323878
00884450297551	00884450297551
00884450278505	00884450278505
00884450324004	00884450324004
10884450357108	00884450357101
10884450357092	00884450357095