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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device central venous catheter tray
Regulation Description Venous blood pressure manometer.
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 CodeOFF
Regulation Number 870.1140
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Advance 1 1
Break 1 1
Crack 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Medical Action Industries, Inc. 306 I May-12-2021
3 Medline Industries, Inc. II Jul-06-2018
4 Resource Optimization & Innovation LLC II Jun-15-2020
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