PreludeSYNC EVO™ SRB24LBAC/B

GUDID 20884450567818

Merit Medical Systems, Inc.

Vascular compressor, external

Primary Device ID	20884450567818
NIH Device Record Key	62cea731-bd38-46b7-b10f-82e971b6ff53
Commercial Distribution Status	In Commercial Distribution
Brand Name	PreludeSYNC EVO™
Version Model Number	10884450567811
Catalog Number	SRB24LBAC/B
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	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	00884450567814 [Unit of Use]
GS1	10884450567811 [Primary]
GS1	20884450567818 [Package] Contains: 10884450567811 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	2021-09-28
Device Publish Date	2021-09-20

On-Brand Devices [PreludeSYNC EVO™]

20884450400443	10884450400446
20884450462946	10884450462949
20884450567870	10884450567873
20884450567818	10884450567811
20884450462953	10884450462956
20884450400467	10884450400460

Trademark Results [PreludeSYNC EVO]

Mark Image Registration \| Serial	Company Trademark Application Date
PRELUDESYNC EVO 88438690 not registered Live/Pending	Merit Medical Systems, Inc. 2019-05-20