DEVICE: AngioDynamics (H965251840)

Device Identifier (DI) Information

AngioDynamics
25184
Not in Commercial Distribution

NAVILYST MEDICAL, INC.
H965251840
HIBCC
April 01, 2021
1
809699023 *Terms of Use
AngioVac Cannula
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34905 Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133445 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 22 French
Outer Diameter: 24 Millimeter
Length: 80 Centimeter
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Device Record Status

9ec19621-a202-46b8-ac22-31990ebae935
June 19, 2024
6
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(518)795-1676
dgreer@angiodynamics.com
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