AccessGUDID - DEVICE: EMBOL-X Intra-Aortic Filter with Duraflo Coating (00690103166330)

GUDID

Device Identifier (DI) Information

Brand Name: EMBOL-X Intra-Aortic Filter with Duraflo Coating
Version or Model: EXXSD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXXSD
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103166330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING

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?
44841	Embolic protection filtering guidewire	A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. 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 [?]
K062429	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
Special Storage Condition, Specify: Store sterile packaged device in a cool, dry, dark place until ready for use.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: ID 22-26 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)

Device Record Status

Public Device Record Key: 0f472e32-e338-46bb-85e2-ed2b52524d29
Public Version Date: April 09, 2019
Public Version Number: 4
DI Record Publish Date: August 31, 2016