BRAEMAR MANUFACTURING, LLC

Address:1285 Corporate Center Dr Ste 150,EAGAN,MN,55121,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

Detector And Alarm, Arrhythmia (DSI) (6) Cable, Electrode (IKD) (2) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (2)

Premarket Exempt

No Yes

Clear

C6 Monitor - B146C6M40 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

BTP-1000M - B146C6M50 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Monitor A10e, Verizon - B146C6M70 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Sensor 2.5 rebuilt - B146C6R10 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Sensor 2.0 rebuilt - B146C6R20 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

BTP-1000S - B146C6S0 Catalog Number :

Device Description : MCOT Holter

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

Cardiokey - B146CK0 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MWJ

Prescription Use : No

Device Count : 1

Cardiokey Leadwire - B146CKL10 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

DL800 Patient Cable - B146DL800 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

DL800 Braemar 256 s/s 10 bit - B146DL8256B0 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MWJ

Prescription Use : No

Device Count : 1

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