ivWatch Patient Monitor 00814088020092

GUDID 00814088020092

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

IVWATCH, LLC

Infiltration/extravasation monitoring system monitor
Primary Device ID00814088020092
NIH Device Record Key45e4a137-b4e9-4fbd-b3ca-dcfbf591b1ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameivWatch Patient Monitor
Version Model NumberModel 400
Catalog Number00814088020092
Company DUNS057028415
Company NameIVWATCH, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone757-705-2461
Emailchuck.egress@ivwatch.com
Phone757-705-2461
Emailchuck.egress@ivwatch.com

Device Dimensions

Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch
Length8 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100814088020092 [Primary]

FDA Product Code

PMSPeripheral Intravenous (Piv) Infiltration Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-25
Device Publish Date2017-07-11

On-Brand Devices [ivWatch Patient Monitor]

00814088020092A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e
00814088020009A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e
00814088020382ivWatch Patient Monitor, Model 400, English, Lease

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