DRAEGER MEDICAL SYSTEMS, INC.

Address:6 TECH DRIVE,ANDOVER,MA,01810,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (7) Oximeter (DQA) (2) System,Network And Communication,Physiological Monitors (MSX) (2) Medical Device Data System (OUG) (1)

Premarket Exempt

No Yes

Clear

ECG Cbl MonoLead 3 AHA/US 4.1m - 04049098001649 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Infinity CentralStation Wide (confi) - 04049098001878 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Innovian SW Care Upgrade - 04049098002011 Catalog Number :

Device Class : 1

Duns Number: 788289952

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

INFINITY M300 Nellcor WPA2 - 04049098002035 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Infinity M300 Masimo WPA2 - 04049098002066 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

ECG NEO ADAPTER CABLE MM, 2M - 04049098002097 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Omega-S Solution - 04049098002172 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MSX, MHX

Prescription Use : No

Device Count : 1

Omega-Solution - 04049098002738 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX, MSX

Prescription Use : No

Device Count : 1

SPO2 NELLCOR POD KIT KAPPA - 04049098002752 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

SPO2 NELLCOR POD KIT DELTA - 04049098002769 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

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