VivePro
GUDID 10810041988567
Ultrasound Gel 5L + 250ml Refill Bottle
VIVE HEALTH LLC
Coupling gel, non-sterile| Primary Device ID | 10810041988567 |
| NIH Device Record Key | 3976c831-c0ef-457f-98fe-d72bb6a6b4f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VivePro |
| Version Model Number | RHB1088SET |
| Company DUNS | 047025993 |
| Company Name | VIVE HEALTH LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810041988560 [Primary] |
| GS1 | 10810041988567 [Package] Contains: 00810041988560 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101952
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
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 | 2021-12-17 |
| Device Publish Date | 2021-12-09 |
Devices Manufactured by VIVE HEALTH LLC
| 10810113575817 - CoreTech | 2024-09-25 971 Ankle Brace (Left) Small |
| 10810113575824 - CoreTech | 2024-09-25 971 Ankle Brace (Left) Medium |
| 10810113575831 - CoreTech | 2024-09-25 971 Ankle Brace (Left) Large |
| 10810113575848 - CoreTech | 2024-09-25 971 Ankle Brace (Right) Small |
| 10810113575855 - CoreTech | 2024-09-25 971 Ankle Brace (Right) Medium |
| 10810113575961 - CoreTech | 2024-09-25 971 Ankle Brace (Right) Large |
| 10810113578177 - ClearWaves | 2024-09-23 Hearing Aids (Advanced) |
| 10810113578184 - ClearWaves | 2024-09-23 Hearing Aids (Empower) |
Trademark Results [VivePro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVEPRO 98713632 not registered Live/Pending |
Alltech, Inc. 2024-08-23 |
 VIVEPRO 88391843 not registered Live/Pending |
Vive Health LLC 2019-04-18 |
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