FloPatch
GUDID 00627987360103
1929803 Ontario Corp
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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