Teleflex LMA Unique™ (Silicone Cuff) Cuff Pilot Laryngeal Mask Airway
- Registration number
- DE0507364
- Model name
- LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 1; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 1.5; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 2; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 2.5; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 3; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 4; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 5; LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 6
- Model identifier
- 105200-000010; 105200-000015; 105200-000020; 105200-000025; 105200-000030; 105200-000040; 105200-000050; 105200-000060
- Registration date
- October 11, 2022
- Source update date
- September 17, 2024
- Risk class
- Class B
- Product owner
- Teleflex Medical
- Registrant / registration holder
- TELEFLEX MEDICAL ASIA PTE. LTD.
The LMA® Unique™ (Silicone Cuff) Cuff Pilot™ is intended to be used to facilitate oxygenation and ventilation. The LMA® Unique™ (Silicone Cuff) Cuff Pilot™ is indicated for use in achieving and maintaining control of, the patient’s airway during routine anesthetic procedures, in fasted patients, using either spontaneous or Positive Pressure Ventilation (PPV). It is also indicated for use as a rescue airway device in Cardiopulmonary Resuscitation (CPR) procedures, in which supraglottic airways have traditionally been used as highlighted in numerous international airway management guidelines. Similarly, it is also indicated as a “rescue airway device” in known, or unexpected difficult airway situations.
- Product owner address
- IDA Business and Technology Park, Dublin Road, Athlone, Co. Westmeath, Ireland
- Registrant address
- 83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.