FDA.reportPublic FDA data

Spiration Valve System

Primary DI
00896506002279
Brand
Spiration Valve System
Company
Gyrus Acmi, Llc
Model
SVS-V7-00
Device description
Valve in Cartridge, 7mm
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
00896506002279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002279008965060022798965060022790896506002279

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 Diameter7Millimeter

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
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

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
00896506002286Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002293Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002309Spiration 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