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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

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