FDA.reportPublic FDA data

ivWatch SmartTouch Sensor

Primary DI
00814088020597
Brand
ivWatch SmartTouch Sensor
Company
IVWATCH, LLC
Model
Model 400
Catalog number
00814088020597
Device description
Disposable, Electronic Sensor
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
20814088020591PackageGS180In Commercial Distribution
00814088020597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081408802059120814088020591
00814088020597008140880205978140880205970814088020597

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous access site infiltration/extravasation monitoring system sensorA noninvasive, electronic component of an infiltration/extravasation monitoring system intended to emit and receive light to/from the skin surface and transmit electronic signals to the system monitor (not included), for the detection of a fluid leak into surrounding tissues at the site of a peripheral intravenous (IV) infusion. It includes an LED light source, photo detector, with an attached electrical cable. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Weight0.03Pound

Regulatory Flags#

DUNS number
057028415
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
00814088020047ivWatch Sensor CableIVWATCH, LLCPMS2016-09-14