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GENTEC®
GENTEC(SHANGHAI)CORPORATION · Model 880VS-760-00-A-00 · UDI-DI 06970966663448
10
510(k) clearances
161
Adverse events (6 deaths)
4
Recalls
29
Facilities
Description
880VS series medical suction kit is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-12 | Ohio Medical Corporation | Final quality control testing was not completed before the devices were distributed.. |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
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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.