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GENTEC®
GENTEC(SHANGHAI)CORPORATION · Model 882VR-300-OE-D · UDI-DI 06970966661925
10
510(k) clearances
128
Adverse events (6 deaths)
4
Recalls
29
Facilities
Description
882VR series suction regulator is a suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc.
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.