BioFlo DuraMax® H965103038031

GUDID 10884450786304

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable
Primary Device ID10884450786304
NIH Device Record Key7d86e19f-9bea-4f4c-bdcb-b4e46a64330f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioFlo DuraMax®
Version Model NumberA
Catalog NumberH965103038031
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450786307 [Primary]
GS110884450786304 [Package]
Contains: 00884450786307
Package: [5 Units]
In Commercial Distribution

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 Date2024-10-09
Device Publish Date2024-10-01

On-Brand Devices [BioFlo DuraMax®]

10884450793296A
10884450786311A
10884450786328A
10884450793838A
10884450793289A
10884450793753A
10884450793319A
10884450793975A
10884450793234A
10884450792374A
00884450794012A
00884450792360A
00884450792353A
00884450793336A
10884450786212A
00884450793329A
00884450793992A
10884450793982A
00884450793244A
00884450794005A
10884450793906A
10884450793302A
10884450793746A
10884450786304A

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