OAZHumanitarian device exemption
One-Way Air-Leak Valve
Unknown
OAZ is the FDA product code for One-Way Air-Leak Valve. FDA's definition for this code reads: "To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- OAZ
- Device name
- One-Way Air-Leak Valve
- FDA definition
- To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
- Device class
- Humanitarian device exemption
- Review panel
- Unknown
- Submission type
- FDA code 6
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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