IVWATCH, LLC

Address:700 Tech Center Parkway, Suite 300,Newport News,VA,23606,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

Peripheral Intravenous (Piv) Infiltration Monitor (PMS) (8) Respirator, Surgical (MSH) (1)

Premarket Exempt

No Yes

Clear

ivWatch Patient Monitor - 00814088020009 Catalog Number : 00814088020009

Device Description : A device to continuously monitor peripheral IVs for the early detection of IV in A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Sensor Receptacle - 00814088020016 Catalog Number :

Device Description : Single-use, sterile sensor receptacle for the ivWatch Model 400.

Device Class :

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Sensor Cable - 00814088020047 Catalog Number :

Device Description : Reusable fiber optic sensor cable for the ivWatch Model 400.

Device Class :

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Patient Monitor - 00814088020092 Catalog Number : 00814088020092

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Patient Cable - 00814088020115 Catalog Number : 00814088020115

Device Description : Reusable, Electronic Patient Cable

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Extension Module - 00814088020122 Catalog Number : 00814088020122

Device Description : A device accessory for the ivWatch Model 400 that provides support for the ivWat A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch Patient Monitor - 00814088020382 Catalog Number : 00814088020382

Device Description : ivWatch Patient Monitor, Model 400, English, Lease

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

ivWatch SmartTouch Sensor - 00814088020597 Catalog Number : 00814088020597

Device Description : Disposable, Electronic Sensor

Device Class : 2

Duns Number: 057028415

Premarket Exempt : No

Product Code : PMS

Prescription Use : Yes

Device Count : 1

blox - 00814088020726 Catalog Number :

Device Description : Surgical N95 Respirator

Device Class :

Duns Number: 057028415

Premarket Exempt : Yes

Product Code : MSH

Prescription Use : No

Device Count : 1

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