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#LubeLife - Flavor Variety Pack 10mL

Model 70154 · CC Wellness LLC · DI 00796494004326

NUC — Lubricant, Personal · Class II · 21 CFR 884.5300

UDILibrary device dossier · generated 2026-09-07 · 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.

11222019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device05070701
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-0701
2023-0702
2025-0102
This device (reports/month)Average device in NUC (reports/device/month)

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