Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

JO Actively Trying (TTC) - Original - Lubricant 4 floz / 120 mL

Model 40081 · CC Wellness LLC · DI 00796494000458

PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible · Class II · 21 CFR 884.5300

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — CC Wellness LLC

  • NAI 2021-09-02 CC Wellness, LLC · 0 citations
  • NAI 2021-09-02 CC Wellness, LLC · 0 citations
  • VAI 2018-03-21 CC Wellness, LLC · 5 citations
  • VAI 2018-03-21 CC Wellness, LLC · 5 citations
  • VAI 2014-01-30 CC Wellness, LLC · 7 citations
  • VAI 2014-01-30 CC Wellness, LLC · 7 citations