FDA.reportPublic FDA data

Spiration Valve System

Primary DI
00896506002118
Brand
Spiration Valve System
Company
Gyrus Acmi, Llc
Model
HUS-C26
Device description
Deployment Catheter and Loader, 2.6
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OAZOne-Way Air-Leak Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAZOne-Way Air-Leak ValveUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H060002005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H060002005

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896506002118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002118008965060021188965060021180896506002118

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
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
00896506002187Spiration Valve SystemGyrus Acmi, LlcOAZ2016-09-24
00896506002200Spiration Valve SystemGyrus Acmi, LlcOAZ2016-09-24
00896506002217Spiration Valve SystemGyrus Acmi, LlcOAZ2016-09-24
00896506002088Spiration Valve SystemGyrus Acmi, LlcOAZ2014-09-23
00896506002095Spiration Valve SystemGyrus Acmi, LlcOAZ2014-09-23
00896506002101Spiration Valve SystemGyrus Acmi, LlcOAZ2014-09-23
00896506002125Spiration Valve SystemGyrus Acmi, LlcOAZ2014-09-23