AccessGUDID - DEVICE: Surge Cardiovascular (00817278010903)

GUDID

Device Identifier (DI) Information

Brand Name: Surge Cardiovascular
Version or Model: PER-1401S-C05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PER-1401S-C05
Company Name: Alliant Enterprises, LLC

Primary DI Number: 00817278010903
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: Multiple Perfusion Set with Vent Line, 15" length, color-coded clamps

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?
58824	Cardioplegia solution administration adaptor	A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). 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: ca4db9f7-9469-4909-a930-8c6d09b255c4
Public Version Date: May 09, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016