AccessGUDID - DEVICE: Quantum SuperPAC Cardioplegia Set 3/16 (08051160301362)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum SuperPAC Cardioplegia Set 3/16
Version or Model: CGSP2-B1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SPECTRUM MEDICAL SRL

Primary DI Number: 08051160301362
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 436188505 *Terms of Use

Device Description: No description.

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":	Yes
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?
16163	Cardioplegia solution administration kit	A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is 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 [?]
K213540	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
No Device Sizes

Device Record Status

Public Device Record Key: 2b28a229-9d58-466b-befd-b0d8584a17c4
Public Version Date: January 05, 2024
Public Version Number: 3
DI Record Publish Date: June 07, 2022