FloPatch
GUDID 00627987360103
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 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 | 00627987360103 |
| NIH Device Record Key | e5f756c4-4531-41aa-9ad2-5381a91410b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 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 | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627987360103 [Primary] |
| GS1 | 10627987360100 [Package] Package: box [10 Units] In Commercial Distribution |
| GS1 | 20627987360107 [Package] Contains: 10627987360100 Package: box [4 Units] In Commercial Distribution |
| GS1 | 30627987360104 [Package] Contains: 10627987360100 Package: box [6 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-10-29 |
| Device Publish Date | 2020-09-22 |
On-Brand Devices [FloPatch]
| 20627987360114 | FP120 |
| 00627987360103 | FP120 |
Trademark Results [FloPatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOPATCH 88191780 not registered Live/Pending |
1929803 Ontario Corp. 2018-11-13 |
 FLOPATCH 87212425 not registered Dead/Abandoned |
1929803 Ontario Corp. 2016-10-22 |
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