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

AirLife

Model 002707 · Carefusion Corporation · DI 10885403170157

NFB — Conserver, Oxygen · Class II · 21 CFR 868.5905

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.

12232020-12: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2/device12080902030802071011120102
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1201
2021-0801
2022-0902
2023-0201
2023-0303
2023-0802
2024-0202
2025-0702
2025-1002
2025-1103
2025-1202
2026-0102
2026-0202
This device (reports/month)Average device in NFB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Carefusion Corporation

  • Warning Letter 2014-06-06 Carefusion 2200 Inc
  • NAI 2025-09-19 Carefusion Corporation · 1 citations
  • NAI 2025-09-19 Carefusion Corporation · 1 citations
  • NAI 2025-09-18 CareFusion DR 203 LTD · 0 citations
  • VAI 2023-09-29 CareFusion 213, LLC · 5 citations
  • NAI 2022-12-08 CAREFUSION · 0 citations
  • NAI 2022-12-08 CAREFUSION · 0 citations
  • VAI 2022-10-19 Carefusion 2200 Inc · 2 citations
  • NAI 2018-11-15 Carefusion 2200 Inc · 0 citations
  • VAI 2018-09-28 Carefusion Corporation · 2 citations
  • VAI 2018-09-28 Carefusion Corporation · 2 citations
  • NAI 2016-12-15 CareFusion 213, LLC · 0 citations
  • VAI 2015-05-07 Carefusion 2200 Inc · 2 citations
  • NAI 2014-12-11 CareFusion Inc · 0 citations
  • NAI 2014-10-30 CareFusion DR 203 LTD · 0 citations
  • VAI 2014-06-20 Carefusion Corporation · 1 citations
  • VAI 2014-06-20 Carefusion Corporation · 1 citations
  • NAI 2014-03-11 CareFusion 213, LLC · 0 citations
  • OAI 2013-11-05 Carefusion 2200 Inc · 7 citations
  • VAI 2011-09-07 Carefusion 2200 Inc · 3 citations
  • OAI 2010-07-30 Carefusion Corporation · 0 citations