FDA.reportPublic FDA data

ivWatch Extension Module

Primary DI
00814088020122
Brand
ivWatch Extension Module
Company
IVWATCH, LLC
Model
Model 400
Catalog number
00814088020122
Device description
A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMSPeripheral Intravenous (Piv) Infiltration Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMSPeripheral Intravenous (Piv) Infiltration MonitorGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192385000ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC2020-07-02PMS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814088020122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814088020122008140880201228140880201220814088020122

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous access site infiltration/extravasation monitoring system transceiverAn electrically-powered component of an infiltration/extravasation monitoring system intended to receive and process the electrical signals acquired from the system’s electronic sensor, and then transmit the signals to the monitor for display to enable detection of a fluid leak into surrounding tissues at the site of a peripheral intravenous (IV) infusion. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth3.8Inch
Length4.1Inch
Weight0.46Pound
Width5.9Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
757-705-2461chuck.egress@ivwatch.com

Regulatory Flags#

DUNS number
057028415
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814088020597ivWatch SmartTouch SensorModel 400008140880205972020-07-17
00814088020115ivWatch Patient CableModel 400008140880201152020-07-17
00814088020726bloxBLX-95012021-11-11
00814088020788bloxBLX-95012021-11-11
20814088020591ivWatch SmartTouch SensorModel 400008140880205972020-07-17
00814088020382ivWatch Patient MonitorModel 400008140880203822019-03-19
00814088020009ivWatch Patient MonitorModel 400008140880200092016-09-14
00814088020016ivWatch Sensor ReceptacleModel 4002016-09-14
00814088020047ivWatch Sensor CableModel 4002016-09-14
00814088020092ivWatch Patient MonitorModel 400008140880200922017-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814088020597ivWatch SmartTouch SensorIVWATCH, LLCPMS2020-07-17
00814088020115ivWatch Patient CableIVWATCH, LLCPMS2020-07-17
20814088020591ivWatch SmartTouch SensorIVWATCH, LLCPMS2020-07-17
00814088020382ivWatch Patient MonitorIVWATCH, LLCPMS2019-03-19
00814088020092ivWatch Patient MonitorIVWATCH, LLCPMS2017-07-11
00814088020009ivWatch Patient MonitorIVWATCH, LLCPMS2016-09-14
00814088020016ivWatch Sensor ReceptacleIVWATCH, LLCPMS2016-09-14
00814088020047ivWatch Sensor CableIVWATCH, LLCPMS2016-09-14