DRAEGER MEDICAL SYSTEMS, INC.

Address:3135 QUARRY RD.,Telford,PA,18969,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) (6) Oximeter (DQA) (4) Medical Device Data System (OUG) (2)

Premarket Exempt

No Yes

Clear

Innovian SW Sub Assembly 7.1 - 04049098047302 Catalog Number :

Device Class : 1

Duns Number: 788289952

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

INFINITY NELLCOR MOUNT KIT - 04049098047838 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : Yes

Product Code : DQA, MHX

Prescription Use : No

Device Count : 1

INFINITY MCABLE-RAINBOW SET - 04049098048484 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Shp Unt M540 Nellcor - 04049098048934 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

SHP UNT M300 PWT WPA2 - 04049098048989 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Shp Exc M300 Masimo PWT - 04049098049023 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

InnovianSW Assemby 7.1 - 04049098049047 Catalog Number :

Device Class : 1

Duns Number: 788289952

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

INFINITY NELLCOR SP02 POD X8 - 04049098049306 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Ship Exc M300 Nellcor PWT - 04049098049405 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

INFINITY MCABLE-NELLCOR OXIMAX - 04049098049665 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : DQA, MHX

Prescription Use : No

Device Count : 1

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