Home GUDID 00814088020009 ivWatch Patient Monitor
Primary DI 00814088020009
Brand ivWatch Patient Monitor
Company IVWATCH, LLC
Model Model 400
Catalog number 00814088020009
Device description A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
Published 2016-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name PMS Peripheral Intravenous (Piv) Infiltration Monitor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PMS Peripheral Intravenous (Piv) Infiltration Monitor General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814088020009 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814088020009 00814088020009 814088020009 0814088020009
GMDN Terms# Term, Definition table Term Definition Infiltration/extravasation monitoring system monitor A portable mains (AC-powered) device intended to be used during intravenous fluid administration to detect and alert healthcare professionals to infiltration/extravasation (leaking of fluid into the surrounding tissues). It includes a display, light source, and a light sensor. Light [visible/near infrared (NIR)] from the monitor is directed to the skin surface near the IV access site, and reflected light from the tissues is directed back to the sensor in the monitor, via a dedicated fibreoptic cable (not included); the monitor is intended to detect changes in reflected light which are processed to indicate fluid leakage.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 2.63 Inch Length 8 Inch Weight 2.5 Pound Width 6.14 Inch
Regulatory Flags# DUNS number 057028415 Device count 1 DM exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00814088020597 ivWatch SmartTouch Sensor IVWATCH, LLC PMS 2020-07-17 00814088020115 ivWatch Patient Cable IVWATCH, LLC PMS 2020-07-17 00814088020122 ivWatch Extension Module IVWATCH, LLC PMS 2020-07-17 20814088020591 ivWatch SmartTouch Sensor IVWATCH, LLC PMS 2020-07-17 00814088020382 ivWatch Patient Monitor IVWATCH, LLC PMS 2019-03-19 00814088020092 ivWatch Patient Monitor IVWATCH, LLC PMS 2017-07-11 00814088020016 ivWatch Sensor Receptacle IVWATCH, LLC PMS 2016-09-14 00814088020047 ivWatch Sensor Cable IVWATCH, LLC PMS 2016-09-14
ivwatch.com