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

Blood Pressure Cuff (DXQ) (5) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (2) Incubator, Neonatal (FMZ) (1) System,Network And Communication,Physiological Monitors (MSX) (1) Unit, Neonatal Phototherapy (LBI) (1)

Premarket Exempt

No Yes

Clear

S/W SUB VF7.0 GATEWAY - 04049098059749 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

S/W SUB VF10.0 INFINITY EXPLORER - 04049098059916 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MSX

Prescription Use : No

Device Count : 1

NIBP Neo #5 Cuff 8.3 - 15 cm - 04049098060523 Catalog Number :

Device Class :

Duns Number: 788289952

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 10

NIBP Neo #1 Cuff 3.1 - 5.7 cm - 04049098060547 Catalog Number :

Device Class :

Duns Number: 788289952

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 10

NIBP Neo #2 Cuff 4.3 - 8 cm - 04049098060578 Catalog Number :

Device Class :

Duns Number: 788289952

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 10

NIBP Neo #3 Cuff 5.8 - 10.9 cm - 04049098060608 Catalog Number :

Device Class :

Duns Number: 788289952

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 10

NIBP Neo #4 Cuff 7.1 - 13.1 cm - 04049098060639 Catalog Number :

Device Class :

Duns Number: 788289952

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 10

Isolette® 8000 plus - 04049098090612 Catalog Number :

Device Description : I8000 plus

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 1

BiliLux Phototherapy Light - 04049098094900 Catalog Number :

Device Description : BiliLux LED Phototherapy System

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

S/W SUB VF7.2 Gateway - 04049098095785 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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