AccessGUDID - DEVICE: Ellipsys Power Controller (00763000478193)

GUDID

Device Identifier (DI) Information

Brand Name: Ellipsys Power Controller
Version or Model: AMI1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVENU MEDICAL, INC.

Primary DI Number: 00763000478193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053562774 *Terms of Use

Device Description: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.

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:	No
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?
45630	Electrocautery system, line-powered	An assembly of line-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191114	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 942db7c3-394f-4775-86a4-0040b12a2773
Public Version Date: December 21, 2022
Public Version Number: 2
DI Record Publish Date: January 27, 2021