Reprocess FloPatch

GUDID 10627987360131

1929803 Ontario Corp

Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe Invasive/noninvasive vascular ultrasound probe

• Primary Device ID: 10627987360131
• NIH Device Record Key: 8ded378f-4aa2-450d-ab6d-e5941ff32f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocess FloPatch
• Version Model Number: FP120
• Company DUNS: 204195374
• Company Name: 1929803 Ontario Corp
• Device Count: 1
• DM Exempt: false
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00627987360134 [Primary]
GS1	10627987360131 [Package]; Contains: 00627987360134; Package: Box [10 Units]; In Commercial Distribution
GS1	20627987360138 [Package]; Package: Box [4 Units]; In Commercial Distribution
GS1	30627987360135 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

Devices Manufactured by 1929803 Ontario Corp

• 10627987360131 - Reprocess FloPatch: 2023-05-16
• 10627987360131 - Reprocess FloPatch: 2023-05-16
• 10627987360148 - Dual Adhesive Strap: 2023-03-13
• 10627987360117 - Hydrogel Adhesive Strap: 2022-06-27
• 00627987360127 - Acrylate Adhesive Strap: 2022-06-27
• 00627987360103 - FloPatch: 2020-10-29
• 20627987360114 - FloPatch: 2020-09-30