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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device cricothyrotomy kit
Regulation Description Tracheostomy tube and tube cuff.
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeOGP
Regulation Number 868.5800
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Aspiration Issue 1 1
Bent 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Activation, Positioning or SeparationProblem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 1 1

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