3100A/B HFOV 766897

GUDID 10190752148840

3100A/B BELLOWS / WATER TRAP

VYAIRE MEDICAL, INC.

Stationary electric high-frequency ventilator
Primary Device ID10190752148840
NIH Device Record Key5b0d1a30-eeb0-4ce7-af55-db1277e32ab2
Commercial Distribution StatusIn Commercial Distribution
Brand Name3100A/B HFOV
Version Model Number766897
Catalog Number766897
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
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110190752148840 [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 Date2021-11-16
Device Publish Date2021-11-08

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