ivWatch Sensor Cable

GUDID 00814088020047

Reusable fiber optic sensor cable for the ivWatch Model 400.

IVWATCH, LLC

Intravenous access monitoring system fibreoptic cable, reusable
Primary Device ID00814088020047
NIH Device Record Keyc40d5a40-4b9d-4b6f-9290-c9522411d04b
Commercial Distribution StatusIn Commercial Distribution
Brand NameivWatch Sensor Cable
Version Model NumberModel 400
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 Batchtrue
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

Length118.1 Inch
Length118.1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100814088020047 [Primary]
GS110814088020044 [Package]
Package: Box [5 Units]
In Commercial Distribution
GS120814088020041 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS130814088020048 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS140814088020045 [Package]
Contains: 30814088020048
Package: Case [40 Units]
In Commercial Distribution
GS150814088020042 [Package]
Contains: 30814088020048
Package: Case [40 Units]
In Commercial Distribution

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 Date2016-09-14

Devices Manufactured by IVWATCH, LLC

00814088020788 - blox2021-11-19 Surgical N95 Respirator
00814088020115 - ivWatch Patient Cable2020-07-27 Reusable, Electronic Patient Cable
00814088020122 - ivWatch Extension Module2020-07-27 A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor
20814088020591 - ivWatch SmartTouch Sensor2020-07-27 Disposable, Electronic Sensor
00814088020382 - ivWatch Patient Monitor2019-07-25 ivWatch Patient Monitor, Model 400, English, Lease
00814088020009 - ivWatch Patient Monitor2019-07-25 A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
00814088020016 - ivWatch Sensor Receptacle2019-07-25 Single-use, sterile sensor receptacle for the ivWatch Model 400.
00814088020047 - ivWatch Sensor Cable2019-07-25Reusable fiber optic sensor cable for the ivWatch Model 400.
00814088020047 - ivWatch Sensor Cable2019-07-25 Reusable fiber optic sensor cable for the ivWatch Model 400.

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