AccessGUDID - DEVICE: EMBOL-X Glide Access Device/Aortic Cannula with Flange (00690103170269)

GUDID

Device Identifier (DI) Information

Brand Name: EMBOL-X Glide Access Device/Aortic Cannula with Flange
Version or Model: EXGF24D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXGF24D
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103170269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: EMBOL-X GLIDE ACCESS DEVICE / AORTIC CANNULA WITH FLANGE

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?
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return	A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102420	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 in a cool, dry, dark place until ready for use.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24 Fr. (8 mm) x 11" (28 cm)

Device Record Status

Public Device Record Key: 89ef390a-4f65-429f-b179-a06d07721dc1
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: August 31, 2016