FDA.reportPublic FDA data

Spiration Valve System

Primary DI
00896506002316
Brand
Spiration Valve System
Company
Gyrus Acmi, Llc
Model
SVS-C26N-06
Device description
Deployment Catheter and Loader, 2.6
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00896506002316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002316008965060023168965060023160896506002316

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial valve delivery catheterA sterile, long, thin, flexible tube designed to deliver and place a non-surgical implantable endobronchial valve, via the working channel of a bronchoscope, into the bronchial lumen of a lung segment. It typically includes a loader; a tool that is used to compress the endobronchial valve and inserts the valve into the catheter. The catheter may be used to deliver multiple size endobronchial valves in a single-patient procedure. This is a single-use device.

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
00896506002279Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002286Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002293Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002309Spiration 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