AccessGUDID - DEVICE: AngioVac (H965252000)

GUDID

Device Identifier (DI) Information

Brand Name: AngioVac
Version or Model: 25-200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Angiodynamics, Inc.

Primary DI Number: H965252000
Issuing Agency: HIBCC
Commercial Distribution End Date: September 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079252781 *Terms of Use

Device Description: AngioVac F18 85 Cannula

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212386	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 105 Centimeter
Catheter Gauge: 18 French
Device Size Text, specify: 18F x 105cm x 85 Degree Tip Angle

Device Record Status

Public Device Record Key: 14f46e28-3e16-44ba-b520-b93507ef7f18
Public Version Date: September 30, 2024
Public Version Number: 5
DI Record Publish Date: November 10, 2021

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)772-6446
Email: customerservice@angiodynamics.com

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