AccessGUDID - DEVICE: Surge Cardiovascular (00817278010149)

GUDID

Device Identifier (DI) Information

Brand Name: Surge Cardiovascular
Version or Model: 213-026
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 213-026
Company Name: Alliant Enterprises, LLC

Primary DI Number: 00817278010149
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 121170653 *Terms of Use

Device Description: Vein graft cannula, blunt tip with check valve

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?
47798	Vascular irrigation cannula, cardiac vessel graft	A sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots after resection. It is typically made of plastic material (e.g., polypropylene) and typically designed with a connector at the proximal end (e.g., is attached to a syringe with a Luer connector) and a ribbed flange at the distal end for a secure connection to the vessel. It may also be used to perfuse the heart through the graft after having done the anastomosis on the coronary artery. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 050c89d8-cb6b-48d3-a9ec-8c34c1acb5d2
Public Version Date: May 09, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016