BLINK DEVICE COMPANY

Address:1530 Westlake Ave N,Seattle,WA,98109,US

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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

Stimulator, Nerve, Peripheral, Electric (KOI) (5)

Premarket Exempt

Clear

TwitchView™ - 00860298001031 Catalog Number :

Device Description : TwitchView™ utilizes advanced electromyography (EMG) to quantify a patient's dep TwitchView™ utilizes advanced electromyography (EMG) to quantify a patient's depth of neuromuscular block. Providing clinicians with reliable, accurate, and real-time data to support drug dosing and reversal timing and helps prevent residual neuromuscular blockade.

Device Class : 2

Duns Number: 105714027

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TwitchView™ - 00860298001048 Catalog Number :

Device Description : A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifie A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifies the clinical workflow by connecting directly to your facility’s electronic medical record or through middleware solutions.

Device Class : 2

Duns Number: 105714027

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

TwitchView™ - 00860298001055 Catalog Number :

Device Description : Supporting infection control, TwitchView™ utilizes a single-patient use Electrod Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies.

Device Class : 2

Duns Number: 105714027

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

TwitchView™ - 00860298001079 Catalog Number :

Device Description : A reusable electrical cable that connects the TwitchView™ monitor to the single- A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array.

Device Class : 2

Duns Number: 105714027

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

TwitchView™ - 00860298001093 Catalog Number :

Device Class : 2

Duns Number: 105714027

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

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