← Back to catalogue

DuraFlow™2

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
DuraFlow™2 FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Model / Reference
A FDA UDI

Identifiers

Catalog Number
H787103012115 FDA UDI
Primary DI / UDI-DI
00884450795026 FDA UDI
FDA Product Code
MSD FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

DuraFlow™2 by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI da8d6390-5394-4c02-96dd-102808552b43 34 fields · synced Jun 9, 2026