Oxitone
GUDID 07290017350004
Pulse Oximetry
OXITONE MEDICAL LTD
Wearable multiple physiological parameter recorder, reusable| Primary Device ID | 07290017350004 |
| NIH Device Record Key | 8955b5e0-4554-4054-a3bf-6e283eb30bc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxitone |
| Version Model Number | 1000M |
| Company DUNS | 533834359 |
| Company Name | OXITONE MEDICAL LTD |
| 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
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com | |
| Phone | +972542699876 |
| ofer.harpak@oxitone.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017350004 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163382
FDA Product Code
| DQA | Oximeter |
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 | 2023-07-12 |
| Device Publish Date | 2023-07-04 |
Trademark Results [Oxitone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXITONE 86499516 5612128 Live/Registered |
Oxitone Medical Ltd. 2015-01-09 |
 OXITONE 72426292 0960210 Dead/Expired |
OLIN CORPORATION 1972-06-05 |
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