AccessGUDID - DEVICE: WATCHMAN FLX™ (08714729860525)

GUDID

Device Identifier (DI) Information

Brand Name: WATCHMAN FLX™
Version or Model: M635WU50350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M635WU50350
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729860525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Left Atrial Appendage Closure Device with Delivery System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
45418	Cardiac defect occluder	An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NGV	System, appendage closure, left atrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130013	035
P130013	041
P130013	043
P130013	050
P130013	052
P130013	053
P130013	056
P130013	060
P130013	064
P130013	065

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
Outer Diameter: 35 Millimeter

Device Record Status

Public Device Record Key: 2a9be51b-cd0a-441f-b917-aa1958d30312
Public Version Date: May 21, 2024
Public Version Number: 12
DI Record Publish Date: July 28, 2020