DEVICE: Ellipsys Power Controller (00763000574710)
Device Identifier (DI) Information
Ellipsys Power Controller
AMI1001
In Commercial Distribution
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution
AVENU MEDICAL, INC.
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
MR Conditional | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K191114 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
2fead12c-71a3-4bbe-a171-72ae44e5c5b9
December 21, 2022
2
December 10, 2021
December 21, 2022
2
December 10, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined