Oxy2Mask

Organization name

Southmedic Inc.

SRN

CA-MF-000005669

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

9 warnings recorded — scroll inside the panel to see all entries.

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

• Actual flow rate required should be prescribed in conjunction with pulse oximetry. Actual FiO2 will vary. Breath rate, depth of breathing and distance of the diffuser from the face will affect performance.

  OTHER

Primary placement in Netherlands; available across 10 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R03010201AIR/OXYGEN MASKS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.