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Berman Airway
ENTER MEDICAL CORPORATION · Model PN-2001 · UDI-DI 04719872108788
BTQ
Prescription
10
510(k) clearances
313
Adverse events (3 deaths)
2
Recalls
127
Facilities
Description
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2017-01-13 | Teleflex Medical | Labeling error |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.