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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device multiple use blood lancet for single patient use only
Definition A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Product CodeQRL
Regulation Number 878.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI POLYSLIDER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSIA DIABETES CARE US INC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FACET TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 2
FACET TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GOSTAR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFUN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILANCE MEDICAL(SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIVIDIA HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 3 3
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 1 1
Fatigue 1 1
Hyperglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Weakness 1 1
Dizziness 1 1
Shaking/Tremors 1 1
Presyncope 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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