DEFIBTECH, L.L.C.

Address:741 BOSTON POST ROAD,SUITE 201,GUILFORD,CT,06437,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

Automated External Defibrillators (Non-Wearable) (MKJ) (6) Compressor, Cardiac, External (DRM) (3) Medical Device Data System (OUG) (1)

Premarket Exempt

No Yes

Clear

Defibtech ARM Connect - 00815098020645 Catalog Number :

Device Class : 2

Duns Number: 128340200

Premarket Exempt : No

Product Code : DRM

Prescription Use : No

Device Count : 1

Defibtech ACC Wrist Straps - 00815098020669 Catalog Number :

Device Class :

Duns Number: 128340200

Premarket Exempt : No

Product Code : DRM

Prescription Use : No

Device Count : 1

Defibtech ACC Event Connect - 00815098020690 Catalog Number :

Device Class : 2

Duns Number: 128340200

Premarket Exempt : No

Product Code : DRM

Prescription Use : No

Device Count : 1

Defibtech AirAware Remote ASI Cellular Module - 00815098020706 Catalog Number :

Device Class : 1

Duns Number: 128340200

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

DDU-100 Lifeline AED with RX activation form - 00815098020737 Catalog Number :

Device Description : DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

DDU-100 Lifeline AED with RX activation form - 00815098020744 Catalog Number :

Device Description : DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year battery pack with 9V Lithium battery (DCF-210), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

DDU-120 Lifeline AED with RX activation form - 00815098020751 Catalog Number :

Device Description : DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

DDU-120 Lifeline AED with RX activation form - 00815098020768 Catalog Number :

Device Description : DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 7 year battery pack with 9V Lithium battery (DCF-210), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

DDU-2300 Lifeline VIEW with RX activation form - 00815098020775 Catalog Number :

Device Description : DDU-2300 Lifeline VIEW, US, English, 1 set Adult Pads (DDP-2001), Quick Start Ca DDU-2300 Lifeline VIEW, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year battery pack (DCF-2003), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

DDU-2450 Lifeline ECG with RX activation form - 00815098020782 Catalog Number :

Device Description : DDU-2450 Lifeline ECG, US, English, 1 set Adult Pads (DDP-2001), Quick Start Car DDU-2450 Lifeline ECG, US, English, 1 set Adult Pads (DDP-2001), Quick Start Card (DAC-2501), Op. Guide (DAC-A2530EN), 4 year battery pack (DCF-2003), prescription activation form

Device Class : 3

Duns Number: 128340200

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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