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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device burn kit without drug
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeOJJ
Regulation Number 878.4022
Device Class 1

MDR Year MDR Reports MDR Events
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 2 2
Communication or Transmission Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
3 ROi CPS LLC II Oct-06-2023
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