AccessGUDID - DEVICE: enableCV OptiSite™ Arterial Perfusion Cannula (00840479401034)

GUDID

Device Identifier (DI) Information

Brand Name: enableCV OptiSite™ Arterial Perfusion Cannula
Version or Model: OPTI16
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENABLECV INC.

Primary DI Number: 00840479401034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119247843 *Terms of Use

Device Description: OptiSite™ Arterial Perfusion Cannula - OPTI16

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
DQR	Cannula, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073559	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 place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16 Fr. (5.3 mm) x 24 cm (9.5")

Device Record Status

Public Device Record Key: 34e32f9c-c106-4590-a427-277d15a1827a
Public Version Date: February 16, 2026
Public Version Number: 1
DI Record Publish Date: February 06, 2026