Hydrogel Adhesive Strap

GUDID 10627987360117

1929803 Ontario Corp

Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe

• Primary Device ID: 10627987360117
• NIH Device Record Key: 7f700a65-1628-42bc-b3ce-e36753334528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrogel Adhesive Strap
• Version Model Number: FP120-FOT01-003
• Company DUNS: 204195374
• Company Name: 1929803 Ontario Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com
• Phone: 2899982982
• Email: cchin@flosonicsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627987360110 [Primary]
GS1	10627987360117 [Package]; Contains: 00627987360110; Package: Bag [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200337

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: 2022-06-27
• Device Publish Date: 2022-06-17

Devices Manufactured by 1929803 Ontario Corp

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