IntelliSystem®

GUDID 10884450021467

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use
Primary Device ID10884450021467
NIH Device Record Key88ae57bc-1a83-4cd0-acc2-49efca7b5d85
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelliSystem®
Version Model Number00884450021460
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450021460 [Primary]
GS110884450021467 [Package]
Contains: 00884450021460
Package: [5 Units]
In Commercial Distribution
GS120884450021464 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2016-09-24

On-Brand Devices [IntelliSystem®]

2088445029800200884450298008
1088445029799200884450297995
1088445029798500884450297988
1088445023697700884450236970
1088445023689200884450236895
1088445002803900884450028032
1088445002459800884450024591
1088445002146700884450021460
1088445000659400884450006597
1088445029801200884450298015

Trademark Results [IntelliSystem]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTELLISYSTEM
INTELLISYSTEM
75499004 2516068 Dead/Cancelled
TeleTech Holdings, Inc.
1998-06-09
INTELLISYSTEM
INTELLISYSTEM
74045483 1667169 Live/Registered
Merit Medical Systems, Inc.
1990-04-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.