Revitalair
GUDID B878430F0
Hyperbaric Chamber
OXAVITA S.R.L.
Hyperbaric chamber, portable| Primary Device ID | B878430F0 |
| NIH Device Record Key | e4d48115-ef01-43fa-89d2-cece7ccd7bcc |
| Commercial Distribution Discontinuation | 2030-03-13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revitalair |
| Version Model Number | 430F |
| Company DUNS | 979052144 |
| Company Name | OXAVITA S.R.L. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com | |
| Phone | 786-416-5587 |
| Jmillan@sigmabiomedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B878430F0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171899
FDA Product Code
| CBF | Chamber, Hyperbaric |
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 | 2024-01-29 |
| Device Publish Date | 2024-01-19 |
Trademark Results [Revitalair]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVITALAIR 87597439 5445132 Live/Registered |
Comfort Products, Inc. 2017-09-06 |
 REVITALAIR 86394506 4819549 Live/Registered |
OXAVITA S.R.L. 2014-09-15 |
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