ivWatch Sensor Cable

Primary DI
00814088020047
Brand
ivWatch Sensor Cable
Company
IVWATCH, LLC
Model
Model 400
Device description
Reusable fiber optic sensor cable for the ivWatch Model 400.
Published
2016-09-14
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814088020044PackageGS15In Commercial Distribution
20814088020041PackageGS110In Commercial Distribution
30814088020048PackageGS110In Commercial Distribution
40814088020045PackageGS140In Commercial Distribution
50814088020042PackageGS140In Commercial Distribution
00814088020047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081408802004410814088020044
2081408802004120814088020041
3081408802004830814088020048
4081408802004540814088020045
5081408802004250814088020042
00814088020047008140880200478140880200470814088020047

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous access monitoring system fibreoptic cable, reusableA noninvasive fibreoptic cord with a distal tip designed for bidirectional transmission of light between an intravenous access monitoring system monitor and the site of peripheral intravenous (IV) infusion during monitoring of infiltration/extravasation (leaking of fluid into the surrounding tissues) and/or line-disconnection. The cable directs light [visible/near infrared (NIR)] from the monitor to the skin surface, and reflected light from the tissues back to the monitor; changes in reflected light are processed to monitor for internal fluid leakage (infiltration/extravasation) and/or external bleeding (associated with line-disconnection). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length118.1Inch

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
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
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
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
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