FDA.reportPublic FDA data

ivWatch Patient Cable

Primary DI
00814088020115
Brand
ivWatch Patient Cable
Company
IVWATCH, LLC
Model
Model 400
Catalog number
00814088020115
Device description
Reusable, Electronic Patient Cable
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
00814088020115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814088020115008140880201158140880201150814088020115

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length144Inch
Weight0.21Pound

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814088020597ivWatch SmartTouch SensorModel 400008140880205972020-07-17
00814088020122ivWatch Extension ModuleModel 400008140880201222020-07-17
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
00814088020122ivWatch Extension ModuleIVWATCH, 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