HeartSpan® HST-085-00

GUDID 00884450312797

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 Cardiac transseptal access set Cardiac transseptal access set
Primary Device ID00884450312797
NIH Device Record Key441acc47-cd4f-43fc-a4a7-9ea8fc32241c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartSpan®
Version Model Number00884450312797
Catalog NumberHST-085-00
Company DUNS065673912
Company NameMerit Medical
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450312797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2017-10-16

On-Brand Devices [HeartSpan®]

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Trademark Results [HeartSpan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTSPAN
HEARTSPAN
87043746 5064437 Live/Registered
Merit Medical Systems, Inc.
2016-05-19
HEARTSPAN
HEARTSPAN
77169337 3680277 Dead/Cancelled
Thomas Medical Products, Inc.
2007-04-30

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