Prelude IDeal™ PID4F23021SC/A

GUDID 20884450381582

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20884450381582
NIH Device Record Key3b2ff970-bbe1-484c-a708-d16bee225e41
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude IDeal™
Version Model Number10884450381585
Catalog NumberPID4F23021SC/A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
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
GS100884450381588 [Unit of Use]
GS100884450381588 [Unit of Use]
GS100884450381588 [Unit of Use]
GS110884450381585 [Primary]
GS110884450381585 [Primary]
GS110884450381585 [Primary]
GS120884450381582 [Package]
Contains: 10884450381585
Package: [4 Units]
In Commercial Distribution
GS120884450381582 [Package]
Contains: 10884450381585
Package: [4 Units]
In Commercial Distribution
GS120884450381582 [Package]
Contains: 10884450381585
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Prelude IDeal™]

2088445031754310884450317546
2088445031774110884450317744
2088445033503510884450335038
2088445033502810884450335021
2088445033500410884450335007
2088445033499110884450334994
2088445032046810884450320461
2088445032045110884450320454
2088445031772710884450317720
2088445031771010884450317713
2088445031770310884450317706
2088445031767310884450317676
2088445031762810884450317621
2088445031761110884450317614
2088445031760410884450317607
2088445031759810884450317591
2088445031758110884450317584
2088445031757410884450317577
2088445031752910884450317522
2088445031751210884450317515
2088445031747510884450317478
2088445031745110884450317454
2088445031739010884450317393
2088445031738310884450317386
2088445031737610884450317379
2088445031736910884450317362
2088445031735210884450317355
2088445031733810884450317331
2088445031732110884450317324
2088445031730710884450317300
2088445031727710884450317270
2088445031724610884450317249
2088445031718510884450317188
2088445031717810884450317171
2088445031713010884450317133
2088445031712310884450317126
2088445031711610884450317119
2088445031709310884450317096
2088445031707910884450317072
2088445031706210884450317065
2088445031705510884450317058
2088445031704810884450317041
2088445031703110884450317034
2088445033501110884450335014
2088445033498410884450334987
2088445031753610884450317539
2088445031748210884450317485
2088445031746810884450317461
2088445031740610884450317409
2088445031721510884450317218

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