ivWatch Sensor Receptacle

Basic Information

• Brand Name: ivWatch Sensor Receptacle
• Primary DI: 00814088020016
• 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: 3907fc88-d7fb-49a4-9b2f-8b64f0c361d1

Device Description

Single-use, sterile sensor receptacle for the ivWatch Model 400.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
62255	Intravenous access site monitoring system fibreoptic cable holder	A noninvasive device designed to hold the tip of an intravenous access site 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 e.g., 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814088020016	GS1
Package	10814088020013	GS1	Inner Pack	50	In Commercial Distribution
Package	20814088020010	GS1	Case	4	In Commercial Distribution
Package	40814088020014	GS1	Case	4	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	0.42	Inch
Width	1.31	Inch
Length	2.25	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity