ivWatch Patient Monitor 00814088020382

GUDID 00814088020382

ivWatch Patient Monitor, Model 400, English, Lease

IVWATCH, LLC

Infiltration/extravasation monitoring system monitor

• Primary Device ID: 00814088020382
• NIH Device Record Key: d3f72774-3b9c-4947-94de-a7e076a4c149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ivWatch Patient Monitor
• Version Model Number: Model 400
• Catalog Number: 00814088020382
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814088020382 [Primary]

FDA Product Code

• PMS: Peripheral Intravenous (Piv) Infiltration Monitor

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-25
• Device Publish Date: 2019-03-19

On-Brand Devices [ivWatch Patient Monitor]

• 00814088020092: A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e
• 00814088020009: A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e
• 00814088020382: ivWatch Patient Monitor, Model 400, English, Lease