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DuraFlow

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
DuraFlow FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
DuraFlow 2 - 15.5F x 22cm DuraFlow2 Hemodialysis Catheter (with Cuff 17cm from Tip) FDA UDI
Model / Reference
10301713 FDA UDI
Description
DuraFlow 2 - 15.5F x 22cm DuraFlow2 Hemodialysis Catheter (with Cuff 17cm from Tip) FDA UDI

Identifiers

Primary DI / UDI-DI
H787103017130 FDA UDI
510(k) Number
K110936 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
Not 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

No

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

Dimensions & Sizes

Size
Catheter Gauge — 15.5 French FDA UDI
Length — 22 Centimeter FDA UDI

DuraFlow by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K110936 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI 9da27382-46db-4210-a9ea-ff4b2b16501d 38 fields · synced Jun 8, 2026