ivWatch Sensor Cable

Basic Information

• Brand Name: ivWatch Sensor Cable
• Primary DI: 00814088020047
• Version / Model: Model 400
• Company Name: IVWATCH, LLC
• Labeler DUNS: 057028415
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: c40d5a40-4b9d-4b6f-9290-c9522411d04b

Device Description

Reusable fiber optic sensor cable for the ivWatch Model 400.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62253	Intravenous access site monitoring system fibreoptic cable, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814088020047	GS1
Package	20814088020041	GS1	Box	10	In Commercial Distribution
Package	10814088020044	GS1	Box	5	In Commercial Distribution
Package	30814088020048	GS1	Box	10	In Commercial Distribution
Package	40814088020045	GS1	Case	40	In Commercial Distribution
Package	50814088020042	GS1	Case	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	118.1	Inch