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(Design) Cardinal Wings

Model TRUAIR3036 · Cardinal Health, Inc. · DI 20885380183611

KME — Bedding, Disposable, Medical · Class I · 21 CFR 880.6060

UDILibrary device dossier · generated 2026-09-13 · 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.

12342019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device0410020509101003071012
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-1001
2020-0201
2020-0501
2021-0903
2021-1002
2022-1002
2023-0304
2023-0701
2023-1002
2024-1202
This device (reports/month)Average device in KME (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cardinal Health, Inc.

  • VAI 2022-07-18 Cardinal Health · 2 citations
  • NAI 2022-06-24 Cardinal Health · 0 citations
  • NAI 2020-02-19 Cardinal Health Inc. · 0 citations
  • VAI 2017-11-15 Cardinal Health LLC · 1 citations
  • NAI 2017-08-30 Cardinal Health LLC · 0 citations
  • NAI 2017-02-15 Cardinal Health · 0 citations
  • VAI 2017-01-25 Cardinal Health · 4 citations
  • VAI 2016-05-12 Cardinal Health · 0 citations
  • NAI 2016-03-23 Cardinal Health LLC · 0 citations
  • NAI 2016-03-17 Cardinal Health LLC. · 0 citations
  • NAI 2015-11-18 Cardinal Health · 0 citations
  • NAI 2015-09-23 Cardinal Health · 0 citations
  • NAI 2015-09-03 Cardinal Health · 0 citations
  • NAI 2015-07-17 Cardinal Health Inc. · 0 citations
  • VAI 2015-04-17 Cardinal Health LLC · 0 citations
  • VAI 2015-03-26 Cardinal Health, Inc · 4 citations
  • NAI 2013-12-05 Cardinal Health · 0 citations
  • NAI 2013-09-09 Cardinal Health · 0 citations
  • NAI 2012-10-31 Cardinal Health Inc. · 0 citations
  • VAI 2012-10-30 Cardinal Health · 1 citations