TRIWALKER SERVICES LLC

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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

Oximeter, Infrared, Sporting, Aviation (OCH) (6) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

TrackAid - 00864984000407 Catalog Number :

Device Description : Dual Mode Digital Infrared Thermometer

Device Class : 2

Duns Number: 080762333

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TrackAid - 00864984000438 Catalog Number :

Device Description : TrackAid Finger Pulse Oximeter TA-60D Dark

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

TrackAid - 00864984000445 Catalog Number :

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

TrackAid - 00864984000452 Catalog Number :

Device Description : TrackAid Fingertip Pulse Oximeter TA-50DL BLUE

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

TrackAid - 00864984000469 Catalog Number :

Device Description : TrackAid Finger Pulse Oximeter TA-50DL Pink

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

TrackAid - 00864984000476 Catalog Number :

Device Description : TrackAid Finger Pulse Oximeter TA-50DL

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

TrackAid - 00864984000490 Catalog Number :

Device Description : TrackAid Fingertip Pulse Oximeter TA-500G White

Device Class : 2

Duns Number: 080762333

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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