AccessGUDID - DEVICE: Amplatzer™ Trevisio™ (05415067030917)

GUDID

Device Identifier (DI) Information

Brand Name: Amplatzer™ Trevisio™
Version or Model: 9-ATV08F45/60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9-ATV08F45/60
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067030917
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Intravascular Delivery System

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?
45419	Cardiac occluder delivery kit	A collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occluder. The devices are used in the treatment of cardiac disorders that may include atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, percutaneous

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
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8.0000 French
Length: 60.0000 Centimeter

Device Record Status

Public Device Record Key: 0d9facef-8062-4ad6-b548-48dd1344db85
Public Version Date: August 31, 2023
Public Version Number: 3
DI Record Publish Date: May 24, 2019