Shikani Speaking Valve

GUDID 00866035000305

Airway Company, The

Tracheostomy tube speech valve
Primary Device ID00866035000305
NIH Device Record Keyca21b56d-6377-4305-8213-fabf925b2fa5
Commercial Distribution StatusIn Commercial Distribution
Brand NameShikani Speaking Valve
Version Model NumberSSV-C
Company DUNS063502758
Company NameAirway Company, The
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866035000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOHTube Tracheostomy And Tube Cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-03
Device Publish Date2019-05-24

On-Brand Devices [Shikani Speaking Valve ]

00866035000312SSV-B
00866035000305SSV-C

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