3100 HFOV 11437-PMN

GUDID 10190752158894

Tube Set, Non-Filtered Patient Circuit

VYAIRE MEDICAL, INC.

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Primary Device ID10190752158894
NIH Device Record Keyaa666a48-16ac-410e-852f-58337cd05f69
Commercial Distribution StatusIn Commercial Distribution
Brand Name3100 HFOV
Version Model Number11437-PMN
Catalog Number11437-PMN
Company DUNS080456871
Company NameVYAIRE MEDICAL, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110190752158894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSZVENTILATOR, HIGH FREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [3100 HFOV]

10190752181472CIRCUIT PORT ADAPTER FOR GAS SAMPLING
10190752160804MICROBLENDER,W/2'/3' H,H/L,HFOV
10190752158900Tube Set, Filtered Patient Circuit
10190752158894Tube Set, Non-Filtered Patient Circuit
10190752158733EXHALED GAS DEFLECTOR
10190752155381Scavenger for 3100A / 3100B High Frequency Oscillatory Ventilators
10190752176218RETAINER PWR CORD INSTRUMENT
10190752155213KIT, 3100 BLENDER BRACKET
50190752148879Expiratory Filter for Patient Circuit
50190752148855Inspiratory Filter for Patient Circuit

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