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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oxygen administration kit
Regulation Description Portable liquid oxygen unit.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGL
Regulation Number 868.5655
Device Class 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Moisture or Humidity Problem 9 9
Disconnection 2 2
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
Decreased Respiratory Rate 2 2
Low Oxygen Saturation 1 1
Exposure to Body Fluids 1 1
Hyperventilation 1 1
Hypoxia 1 1
Increased Respiratory Rate 1 1
No Patient Involvement 1 1
No Information 1 1

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