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EvenMore

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
EvenMore FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
14.5F x 24cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 19cm from Tip) FDA UDI
Model / Reference
10303607 FDA UDI
Description
14.5F x 24cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 19cm from Tip) FDA UDI

Identifiers

Primary DI / UDI-DI
H787103036070 FDA UDI
510(k) Number
K040402 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
Length — 24 Centimeter FDA UDI
Catheter Gauge — 14.5 French FDA UDI

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

Cleared under the same submission

K040402 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 b8d8a303-1e09-48a1-89cd-76579a16c83f 38 fields · synced Jun 8, 2026