ivWatch SmartTouch Sensor 00814088020597

GUDID 20814088020591

Disposable, Electronic Sensor

IVWATCH, LLC

Intravenous access site infiltration/extravasation monitoring system sensor
Primary Device ID20814088020591
NIH Device Record Keyff0e82d2-6001-40c8-8904-82ebd38da82e
Commercial Distribution StatusIn Commercial Distribution
Brand NameivWatch SmartTouch Sensor
Version Model NumberModel 400
Catalog Number00814088020597
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch
Weight0.03 Pound
Length18 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100814088020597 [Primary]
GS120814088020591 [Package]
Contains: 00814088020597
Package: Case [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMSPeripheral Intravenous (Piv) Infiltration Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

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 Sensor2020-07-27Disposable, Electronic 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 Cable2019-07-25 Reusable fiber optic sensor cable for the ivWatch Model 400.

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