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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device breast pump 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 CodeOHH
Regulation Number 884.5160
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2019 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 2 2
Connection Problem 1 1
Insufficient Information 1 1
Backflow 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Rash 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medela Inc II May-27-2011
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