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AngioDynamics

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name
AngioDynamics FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
Device Name
AngioVac Cannula FDA UDI
Model / Reference
25185 FDA UDI
Description
AngioVac Cannula FDA UDI

Identifiers

Primary DI / UDI-DI
H965251850 FDA UDI
510(k) Number
K142593 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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 — 22 French FDA UDI
Length — 80 Centimeter FDA UDI
Outer Diameter — 28 Millimeter FDA UDI

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

AngioDynamics by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage.

Cleared under the same submission

K142593 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Navilyst Medical, Inc.

Sources (1)

  • FDA UDI 9e8208ad-0b3f-43b9-80bf-a8874d36f7d5 36 fields · synced May 30, 2026