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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood specimen collection kit (excludes hiv testing)
Regulation Description Arterial blood sampling kit.
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 CodeOFZ
Regulation Number 868.1100
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Device Contamination with Chemical or Other Material 1 1
Fluid Leak 1 1
Incorrect Or Inadequate Test Results 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Exposure to Body Fluids 2 2
No Consequences Or Impact To Patient 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Action Industries, Inc. 306 I May-12-2021
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