ivWatch Sensor Receptacle

GUDID 00814088020016

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

IVWATCH, LLC

Infiltration/extravasation monitoring system fibreoptic cable holder

• Primary Device ID: 00814088020016
• NIH Device Record Key: 3907fc88-d7fb-49a4-9b2f-8b64f0c361d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ivWatch Sensor Receptacle
• Version Model Number: Model 400
• Company DUNS: 057028415
• Company Name: IVWATCH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 757-705-2461
• Email: chuck.egress@ivwatch.com
• Phone: 757-705-2461
• Email: chuck.egress@ivwatch.com

Device Dimensions

• Length: 2.25 Inch
• Length: 2.25 Inch
• Length: 2.25 Inch
• Length: 2.25 Inch
• Length: 2.25 Inch
• Length: 2.25 Inch

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814088020016 [Primary]
GS1	10814088020013 [Package]; Package: Inner Pack [50 Units]; In Commercial Distribution
GS1	20814088020010 [Package]; Contains: 10814088020013; Package: Case [4 Units]; In Commercial Distribution
GS1	40814088020014 [Package]; Contains: 10814088020013; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• PMS: Peripheral Intravenous (Piv) Infiltration Monitor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-25
• Device Publish Date: 2016-09-14

Devices Manufactured by IVWATCH, LLC

• 00814088020788 - blox: 2021-11-19 Surgical N95 Respirator
• 00814088020115 - ivWatch Patient Cable: 2020-07-27 Reusable, Electronic Patient Cable
• 00814088020122 - ivWatch Extension Module: 2020-07-27 A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor
• 20814088020591 - ivWatch SmartTouch Sensor: 2020-07-27 Disposable, Electronic Sensor
• 00814088020382 - ivWatch Patient Monitor: 2019-07-25 ivWatch Patient Monitor, Model 400, English, Lease
• 00814088020009 - ivWatch Patient Monitor: 2019-07-25 A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
• 00814088020016 - ivWatch Sensor Receptacle: 2019-07-25Single-use, sterile sensor receptacle for the ivWatch Model 400.
• 00814088020016 - ivWatch Sensor Receptacle: 2019-07-25 Single-use, sterile sensor receptacle for the ivWatch Model 400.
• 00814088020047 - ivWatch Sensor Cable: 2019-07-25 Reusable fiber optic sensor cable for the ivWatch Model 400.