AccessGUDID - DEVICE: TRILLIUM® AFFINITY® (00885074252223)

GUDID

Device Identifier (DI) Information

Brand Name: TRILLIUM® AFFINITY®
Version or Model: 353T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00885074252223
Issuing Agency: GS1
Commercial Distribution End Date: February 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: FILTER 353T AFFINITY 20M TRILLIUM 6PK

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):	No
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?
33309	Cardiopulmonary bypass system filter, arterial blood line	A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTM	Filter, blood, cardiopulmonary bypass, arterial line

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 MIC Filter Pore Size

Device Record Status

Public Device Record Key: 2f1cef90-cce3-43a1-9373-d0cb72baa9a0
Public Version Date: February 07, 2025
Public Version Number: 4
DI Record Publish Date: June 17, 2016