ivWatch SmartTouch Sensor 00814088020597

GUDID 20814088020591

Disposable, Electronic Sensor

IVWATCH, LLC

Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor Intravenous access site infiltration/extravasation monitoring system sensor

• Primary Device ID: 20814088020591
• NIH Device Record Key: ff0e82d2-6001-40c8-8904-82ebd38da82e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ivWatch SmartTouch Sensor
• Version Model Number: Model 400
• Catalog Number: 00814088020597
• Company DUNS: 057028415
• Company Name: IVWATCH, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch
• Weight: 0.03 Pound
• Length: 18 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814088020597 [Primary]
GS1	20814088020591 [Package]; Contains: 00814088020597; Package: Case [80 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192385

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

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: 2020-07-27Disposable, Electronic 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: 2019-07-25 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.