FDA.reportPublic FDA data

Spiration Valve System

Primary DI
00896506002309
Brand
Spiration Valve System
Company
Gyrus Acmi, Llc
Model
SVS-V9-00
Device description
Valve in Cartridge, 9mm
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NJKValve, Pulmonary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJKValve, PulmonaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180007000Spiration® Valve SystemGyrus Acmi, Inc.2018-12-03NJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896506002309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002309008965060023098965060023090896506002309

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial valveA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117521967
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811907030423Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2019-08-23
00811907031222Zephyr Delivery CatheterPULMONX CORPORATIONNJK2019-08-23
00896506002279Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002286Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002293Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002316Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002323Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00811907030126Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030225Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030324Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030522Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20
00811907030621Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20
00811907030720Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20