BioFlo DuraMax® H965103038211

GUDID 10884450793982

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable

Primary Device ID	10884450793982
NIH Device Record Key	7f300d33-aa9d-4f37-ae5d-edcacf49376b
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioFlo DuraMax®
Version Model Number	A
Catalog Number	H965103038211
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450793985 [Primary]
GS1	10884450793982 [Package] Contains: 00884450793985 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K131260

FDA Product Code

MSD	Catheter, hemodialysis, implanted

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-09-16
Device Publish Date	2024-09-07

On-Brand Devices [BioFlo DuraMax®]

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