Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

ResScan

FDA UDI

RESMED PTY LTD·00619498313358·RESSCAN V6.0.2 CD ASSY

AVEA

FDA UDI

Carefusion Corporation·10846446064865·KIT,AVEA UPGRADE GDE,UIM & SOFTWARE

AVEA

FDA UDI

Carefusion Corporation·10846446000979·KIT,AVEA UPGRADE UIM & SOFTWARE

AirMini app

FDA UDI

RESMED PTY LTD·00619498222445·Android

Puritan Bennett

FDA UDI

Covidien LP·10884521640887·800 Series Options Kit, Italian, 840 Neonatal V...

AirView

FDA UDI

RESMED CORP.·00840193400108·AirView

myAir

FDA UDI

RESMED CORP.·00840193400115·myAir (iOS)

EasyCare Tx

FDA UDI

RESMED PTY LTD·00619498259441·EasyCare Tx CD ASSY

Puritan Bennett

FDA UDI

Covidien LP·10884521643291·800 Series Options Kit, German, NeoMode

ResScan

FDA UDI

RESMED PTY LTD·00619498313365·ResScan V6.1 CD ASSY

Puritan Bennett

FDA UDI

Covidien LP·10884521640894·800 Series Options Kit, Polish, 840 Neonatal Ve...

Puritan Bennett

FDA UDI

Covidien LP·10884521211551·IE Sync Trigger Software Update

Puritan Bennett

FDA UDI

Covidien LP·10884521609181·NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY IN...

Puritan Bennett

FDA UDI

Covidien LP·10884521803305·980 Neonatal Expiratory Filtration System, Disp...

Fisher & Paykel Healthcare

FDA UDI

FISHER & PAYKEL HEALTHCARE LIMITED·09420012424990·INFOSMART CD

AVEA

FDA UDI

Carefusion Corporation·10846446017564·AVEA NIMV+VG SW KEY

Puritan Bennett

FDA UDI

Covidien LP·10884521640917·800 Series Options Kit, Russian, 840 Neonatal V...

iCodeConnect Software

FDA UDI

BMC Medical Co., Ltd.·06948538362075·iCodeConnect Software

AirView

FDA UDI

RESMED PTY LTD·00619498000845·AirView