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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, blood, non-electromagnetic radiation
Product CodeBSB
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 10 10
2015 11 11
2016 66 66
2017 29 29
2018 36 36
2019 147 147
2020 216 216
2021 341 341
2022 447 447
2023 292 292
2024 205 205

Recalls
Manufacturer Recall Class Date Posted
1 Estill Medical Technologies, Inc II Oct-21-2014
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