Emitter
GUDID 00860001123425
OXOS Medical, Inc.
Hand-held basic diagnostic x-ray system, digital| Primary Device ID | 00860001123425 |
| NIH Device Record Key | c16e7dfe-b884-4260-8070-8d13593dc9f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Emitter |
| Version Model Number | E1 |
| Company DUNS | 080323883 |
| Company Name | OXOS Medical, Inc. |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 29.9 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Between 1000 ft below sea level and 8,000 ft above sea level |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001123425 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241567
FDA Product Code
| OWB | Interventional Fluoroscopic X-Ray System |
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 | 2025-01-09 |
| Device Publish Date | 2025-01-01 |
Devices Manufactured by OXOS Medical, Inc.
| 00860001123418 - Cassette | 2025-01-09 |
| 00860001123425 - Emitter | 2025-01-09 |
| 00860001123425 - Emitter | 2025-01-09 |
| 00860008892706 - Foot Pedal | 2025-01-09 |
| 00860008892713 - Wired Charger | 2025-01-09 |
| 00860008892737 - Cart | 2025-01-09 |
| 00860008892744 - MC2 App | 2025-01-09 |
| 00860008892782 - MC2 Portable X-ray System | 2025-01-09 |
| 00860008892751 - Micro C Load Bearing Cassette Plate, ACSY-S009 | 2022-10-27 |
Trademark Results [Emitter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMITTER 79190654 5153309 Live/Registered |
Futura GmbH 2016-03-30 |
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