DEVICE: Spiration Valve System (00896506002095)
Device Identifier (DI) Information
Spiration Valve System
HUS-V6
In Commercial Distribution
Gyrus Acmi, Inc.
HUS-V6
In Commercial Distribution
Gyrus Acmi, Inc.
Valve in Cartridge, 6mm
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
47613 | Endobronchial valve |
A sterile, non-surgical implantable device designed to be placed in a bronchial lumen to control bronchial airflow and improve health status, typically in a patient with emphysema and/or to reduce bronchial air leaks. It consists of a one-way valve that includes an expanding frame (e.g., Nitinol) with features to prevent migration after implantation, and a plastic membrane. It is intended to limit airflow distal to the valve while allowing mucus and air movement proximally. This results in the valve redirecting air to healthy portions of the lungs and/or venting lung segments to achieve pneumoreduction. The valve may remain permanently implanted or removed when medical indicated.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAZ | One-Way Air-Leak Valve |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
H060002 | 005 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 6 Millimeter |
Device Record Status
a41b8024-bfe0-4aa9-b55e-b5b7e19c8b81
March 04, 2021
4
September 23, 2014
March 04, 2021
4
September 23, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined