Infant Flow SiPAP 27444-001

GUDID 10190752164871

KIT, SIPAP IF, COMP, AUX, NIST, ENGLISH

VYAIRE MEDICAL, INC.

Neonatal intensive-care ventilator
Primary Device ID10190752164871
NIH Device Record Key21787aaf-18ce-46d2-8b15-166d7b02bdaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfant Flow SiPAP
Version Model Number27444-001
Catalog Number27444-001
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS110190752164871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-30
Device Publish Date2021-03-22

On-Brand Devices [Infant Flow SiPAP]

10190752164888KIT, SIPAP IF, PLUS, AUX, NIST, ICONS
10190752164864KIT,SIPAP,IF,COMP,AUX,MDISS,ENGLISH
10190752161948KIT, SIPAP IF, COMP, AUX, MDISS, ICONS
10190752161931KIT, SIPAP IF, COMP, AUX, SIS, ENGLISH
10190752161924KIT,SIPAP,IF,COMP,AUX,FDISS,ENGLISH
10190752161917KIT, SIPAP, IF, PLUS, AUX, MDISS, ENGLISH
10190752164871KIT, SIPAP IF, COMP, AUX, NIST, ENGLISH

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