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

Incubator, Neonatal (FMZ) (3) Bilirubin (Total And Unbound) In The Neonate Test System (MQM) (2) Incubator, Neonatal Transport (FPL) (2) Warmer, Infant Radiant (FMT) (2) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1)

Premarket Exempt

No Yes

Clear

Isolette 8000 plus - 04048675020530 Catalog Number :

Device Description : Incubator, neonatal

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 1

S/W SUB VF7.1 GATEWAY - 04048675445876 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Drager Jaundice Meter, model JM-103 - 04049098000161 Catalog Number :

Device Class : 1

Duns Number: 788289952

Premarket Exempt : No

Product Code : MQM

Prescription Use : No

Device Count : 1

Isolette 8000 Infant Incubator - 04049098000178 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Resuscitaire Birthing Room Warmer (WBR82) - 04049098000185 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

TI500 Globetrotter Neonatal Transport System - 04049098000192 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

Isolette TI500 Transport Incubator - 04049098000208 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

Resuscitaire Radiant Warmer (RW82, RW82 VHA) - 04049098000215 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

Isolette Infant Incubator, Models C2000 and C2000e - 04049098000222 Catalog Number :

Device Class : 2

Duns Number: 788289952

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Drager Jaundice Meter, model JM-105 - 04049098000246 Catalog Number :

Device Class : 1

Duns Number: 788289952

Premarket Exempt : No

Product Code : MQM

Prescription Use : No

Device Count : 1

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