AccessGUDID - DEVICE: Amplatzer™ (05415067036025)

GUDID

Device Identifier (DI) Information

Brand Name: Amplatzer™
Version or Model: ASDS-14F-075
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ASDS-14F-075
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067036025
Issuing Agency: GS1
Commercial Distribution End Date: February 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Steerable Delivery Sheath

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 75.0000 Centimeter

Device Record Status

Public Device Record Key: f04b35d2-8068-4399-bee6-3b7a6a816390
Public Version Date: August 14, 2024
Public Version Number: 2
DI Record Publish Date: November 09, 2021