TSX™ FCL-191-02

GUDID 00884450265604

Merit Medical

Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set

Primary Device ID	00884450265604
NIH Device Record Key	13df8822-0fe9-44b6-852e-487d129218f4
Commercial Distribution Status	In Commercial Distribution
Brand Name	TSX™
Version Model Number	00884450265604
Catalog Number	FCL-191-02
Company DUNS	065673912
Company Name	Merit Medical
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	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	00884450265604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132720

FDA Product Code

DYB	INTRODUCER, 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	4
Public Version Date	2019-01-23
Device Publish Date	2017-03-09

On-Brand Devices [TSX™]

00884450265680	00884450265680
00884450265673	00884450265673
00884450265666	00884450265666
00884450265659	00884450265659
00884450265642	00884450265642
00884450265635	00884450265635
00884450265628	00884450265628
00884450265611	00884450265611
00884450265604	00884450265604
00884450265598	00884450265598
00884450265581	00884450265581