Shikani HME

GUDID 00866035000343

Airway Company, The

Heat/moisture exchanger, single-use
Primary Device ID00866035000343
NIH Device Record Keye0f36bb1-17fc-4723-8080-961f7fd7d25e
Commercial Distribution StatusIn Commercial Distribution
Brand NameShikani HME
Version Model NumberS-HME
Company DUNS063502758
Company NameAirway Company, The
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100866035000343 [Primary]
GS110866035000340 [Unit of Use]
GS120866035000347 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

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

Devices Manufactured by Airway Company, The

00866035000305 - Shikani Speaking Valve 2019-06-03
00866035000312 - Shikani Speaking Valve2019-06-03
00866035000343 - Shikani HME2019-06-03
00866035000343 - Shikani HME2019-06-03
00866035000350 - Shikani HME Oxygen Tube2019-06-03

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