Cellvizio® I.V.E.
GUDID 03760187913001
MAUNA KEA TECHNOLOGIES
Confocal endomicroscopy system| Primary Device ID | 03760187913001 |
| NIH Device Record Key | eaf77aec-6ff6-448d-a525-1d59fa8a5121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cellvizio® I.V.E. |
| Version Model Number | FP-10001 |
| Company DUNS | 394136118 |
| Company Name | MAUNA KEA TECHNOLOGIES |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 03760187912004 [Previous] |
| GS1 | 03760187913001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193416
FDA Product Code
| OWN | Confocal Optical Imaging |
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 | 2024-03-07 |
| Device Publish Date | 2024-02-28 |
On-Brand Devices [Cellvizio® I.V.E.]
| 03760187912004 | FP-10001 |
| 03760187913001 | FP-10001 |
Trademark Results [Cellvizio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLVIZIO 79002769 3011583 Live/Registered |
MAUNA KEA TECHNOLOGIES 2004-03-05 |
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