BioFlo DuraMax® H965103028070

GUDID 00884450793244

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable
Primary Device ID00884450793244
NIH Device Record Key6e5b0ee3-cd71-42d9-92f1-d98f8f378bb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFlo DuraMax®
Version Model NumberA
Catalog NumberH965103028070
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450793244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSDCatheter, hemodialysis, implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-16
Device Publish Date2024-09-06

On-Brand Devices [BioFlo DuraMax®]

10884450793296A
10884450786311A
10884450786328A
10884450793838A
10884450793289A
10884450793753A
10884450793319A
10884450793975A
10884450793234A
10884450792374A
00884450794012A
00884450792360A
00884450792353A
00884450793336A
10884450786212A
00884450793329A
00884450793992A
10884450793982A
00884450793244A

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