None

Trade name

not provided

16973077632638

697307763LMA09KB

Reference / catalog number

None

GS1

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

10

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• R01020102LARYNGEAL MASKS, DOUBLE-LUMEN

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  This device must not be used in the case of the following: 1. Patients who have had radiotherapy to the neck involving the hypopharynx as there is risk of trauma and/or a potential failure to seal effectively. 2. Patients with inadequate mouth opening to permit insertion. 3. Patients presenting for emergency surgery who are at risk of massive reflux due to such conditions as acute intestinal obstruction or ileus, or patients who have been injured shortly after ingesting a substantial meal (see above under Indications for Use). 4. Patients requiring head or neck surgery where the surgeon will be unable to gain adequate access due to the presence of the device. 5. Patients undergoing CPR who are responsive with an intact gag reflex. 6. Patients who have ingested caustic substances. 7. Do not attempt to pass a gastric tube into the stomach through a drainage tube when esophageal lesions are known or suspected. 8. There is a theoretical risk of edema or hematoma if suction is applied directly to the end of the drainage tube 9. In some cases, the benefits of using this product to establish ventilation must be weighed against the potential risk of aspiration, including: symptomatic or untreated gastroesophageal reflux; Pregnancy beyond 14 weeks; Multiple or extensive lesions; Opioid use in patients with conditions associated with delayed gastric emptying, such as acute injury or peritoneal infection or inflammatory processes 10. Use water-soluble lubricants rather than silicon-based lubricants as they degrade equipment components. Lubricants containing lidocaine are not recommended. Lidocaine delays recovery of protective reflexes after product removal; May cause an allergic reaction, or may affect surrounding organs, including the vocal cords 11. The product can be flammable in the presence of lasers and electric cauterizing equipment