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GENTEC®
GENTEC(SHANGHAI)CORPORATION · Model 881VR-160-OH-T · UDI-DI 06970966660751
10
510(k) clearances
99
Adverse events (6 deaths)
4
Recalls
29
Facilities
Description
881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent)
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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