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Tubing, Long Term Support Greater Than 6 Hours

FDA product code QWF · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4100
Review panel
CV
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2023-04-19 – 2023-04-19

The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.

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