PreludeSYNC™ SDRB-REG-RT/A

GUDID 20884450525573

Merit Medical Systems, Inc.

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Primary Device ID	20884450525573
NIH Device Record Key	76ab69eb-c059-425c-a030-e325b60c5fa7
Commercial Distribution Status	In Commercial Distribution
Brand Name	PreludeSYNC™
Version Model Number	10884450525576
Catalog Number	SDRB-REG-RT/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	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	00884450525579 [Unit of Use]
GS1	10884450525576 [Primary]
GS1	20884450525573 [Package] Contains: 10884450525576 Package: [4 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180723

FDA Product Code

DXC	CLAMP, VASCULAR

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	2021-07-22
Device Publish Date	2021-07-14

On-Brand Devices [PreludeSYNC™]

20884450411494	10884450411497
20884450411517	10884450411510
20884450411197	10884450411190
10884450445201	10884450445201
20884450525573	10884450525576
20884450525214	10884450525217
20884450411500	10884450411503
10884450363673	10884450363673
10884450363659	10884450363659
20884450360297	10884450360290
20884450358942	10884450358945
20884450358935	10884450358938
20884450286900	10884450286903
20884450286894	10884450286897
20884450286887	10884450286880
20884450286870	10884450286873
10884450286538	10884450286538
20884450567825	10884450567828
20884450567788	10884450567781
20884450567832	10884450567835
20884450567887	10884450567880