FDA.reportPublic FDA data

Spiration Valve System

Primary DI
00896506002125
Brand
Spiration Valve System
Company
Gyrus Acmi, Llc
Model
HUS-SK
Device description
Airway Sizing Kit
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00896506002125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002125008965060021258965060021250896506002125

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial airway sizing kitA sterile collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient's lung airways (bronchial lumens). It typically consists of a glass syringe and a plastic calibration gauge with holes representing available endobronchial valve sizes. The syringe is used for filling the balloon with a medium (e.g., sterile saline). Using the same balloon catheter, the volume reading on the syringe made with the balloon in the airway is compared against the volume readings taken with the calibration gauge to select the proper valve size needed for an airway. 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
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

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
00896506002118Spiration Valve SystemGyrus Acmi, LlcOAZ2014-09-23