Spiration Valve System

GUDID 00896506002118

Deployment Catheter and Loader, 2.6

Gyrus Acmi, Inc.

Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter Endobronchial valve delivery catheter
Primary Device ID00896506002118
NIH Device Record Keyc927556f-f4ee-448d-8dec-7b7391b05a58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiration Valve System
Version Model NumberHUS-C26
Company DUNS117521967
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896506002118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAZOne-Way Air-Leak Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-03-04
Device Publish Date2014-09-23

On-Brand Devices [Spiration Valve System]

00896506002217Airway Sizing Kit
00896506002200Valve in Cartridge, 9mm
00896506002187Deployment Catheter and Loader, 2.6
00896506002125Airway Sizing Kit
00896506002118Deployment Catheter and Loader, 2.6
00896506002101Valve in Cartridge, 7mm
00896506002095Valve in Cartridge, 6mm
00896506002088Valve in Cartridge , 5mm

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