OXYMAG 1606880
GUDID 07898671250175
EMERGENCY AND TRANSPORT VENTILATOR
MAGNAMED TECNOLOGIA MEDICA SA
Transport electric ventilator| Primary Device ID | 07898671250175 |
| NIH Device Record Key | 8657e6d0-0ecb-4d81-86b7-27c571042608 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OXYMAG |
| Version Model Number | 1606880 |
| Catalog Number | 1606880 |
| Company DUNS | 944224603 |
| Company Name | MAGNAMED TECNOLOGIA MEDICA SA |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com | |
| Phone | +1 (954) 533-7470 |
| contact@magnamedusa.com |
Device Dimensions
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
| Weight | 3 Kilogram |
| Height | 231 Millimeter |
| Width | 254 Millimeter |
| Depth | 185 Millimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 110 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 75 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07898671250175 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221634
FDA Product Code
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
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 | 2023-12-14 |
| Device Publish Date | 2023-12-06 |
Devices Manufactured by MAGNAMED TECNOLOGIA MEDICA SA
| 07898671250168 - KIT DISPOSABLE RESPIRATORY CIRCUIT | 2025-05-02 DUAL LIMB BREATHING CIRCUIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, DIAPHRAGM, AND HME FILTER FOR USE WI |
| 07898671250175 - OXYMAG | 2023-12-14EMERGENCY AND TRANSPORT VENTILATOR |
| 07898671250175 - OXYMAG | 2023-12-14 EMERGENCY AND TRANSPORT VENTILATOR |
Trademark Results [OXYMAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYMAG 72203389 0801148 Live/Registered |
FMC CORPORATION 1964-10-06 |
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