AccessGUDID - DEVICE: CardioGard Emboli Protection Cannula (07290016069013)

GUDID

Device Identifier (DI) Information

Brand Name: CardioGard Emboli Protection Cannula
Version or Model: CGT2422
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CGT2422
Company Name: CARDIOGARD MEDICAL LTD

Primary DI Number: 07290016069013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533658675 *Terms of Use

Device Description: 24 Fr. (8.00 mm) Cardiopulmonary bypass cannula, arterial, for use in aorta, with suction port in tip to allow emboli removal during cardiopulmonary bypass.

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?
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return	A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial 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 [?]
K182302	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
Circumference: 8.00 Millimeter

Device Record Status

Public Device Record Key: e74d214c-7714-4d16-a323-613d89359824
Public Version Date: June 19, 2024
Public Version Number: 3
DI Record Publish Date: June 01, 2022