ivWatch Sensor Receptacle

GUDID 00814088020016

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

IVWATCH, LLC

Infiltration/extravasation monitoring system fibreoptic cable holder Infiltration/extravasation monitoring system fibreoptic cable holder
Primary Device ID00814088020016
NIH Device Record Key3907fc88-d7fb-49a4-9b2f-8b64f0c361d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameivWatch Sensor Receptacle
Version Model NumberModel 400
Company DUNS057028415
Company NameIVWATCH, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Length2.25 Inch
Length2.25 Inch
Length2.25 Inch
Length2.25 Inch
Length2.25 Inch
Length2.25 Inch

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814088020016 [Primary]
GS110814088020013 [Package]
Package: Inner Pack [50 Units]
In Commercial Distribution
GS120814088020010 [Package]
Contains: 10814088020013
Package: Case [4 Units]
In Commercial Distribution
GS140814088020014 [Package]
Contains: 10814088020013
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

PMSPeripheral Intravenous (Piv) Infiltration Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 Receptacle2019-07-25Single-use, sterile sensor receptacle for the ivWatch Model 400.
00814088020016 - ivWatch Sensor Receptacle2019-07-25 Single-use, sterile sensor receptacle 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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