ivWatch Sensor Receptacle

Primary DI
00814088020016
Brand
ivWatch Sensor Receptacle
Company
IVWATCH, LLC
Model
Model 400
Device description
Single-use, sterile sensor receptacle for the ivWatch Model 400.
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
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
10814088020013PackageGS150In Commercial Distribution
20814088020010PackageGS14In Commercial Distribution
40814088020014PackageGS14In Commercial Distribution
00814088020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081408802001310814088020013
2081408802001020814088020010
4081408802001440814088020014
00814088020016008140880200168140880200160814088020016

GMDN Terms#

Term, Definition table
TermDefinition
Infiltration/extravasation monitoring system fibreoptic cable holderA sterile noninvasive device designed to hold the tip of an infiltration/extravasation monitoring system fibreoptic cable to the skin surface near the site of peripheral intravenous (IV) infusion. It is intended to enable the bidirectional transmission of light between the fibreoptic cable and the skin surface, during monitoring of infiltration/extravasation (leaking of fluid into the surrounding tissues). It is typically a plastic housing with an underlying, transparent, skin-adherent patch. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.42Inch
Length2.25Inch
Width1.31Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057028415
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
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
00814088020047ivWatch Sensor CableIVWATCH, LLCPMS2016-09-14