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N/A PT101USR

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10190752102484 UDI-DI Date4 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0158-2026 FDA Class II initiated 18 Sep 2025

    When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.

    • Ongoing Z-1823-2024 FDA Class II initiated 2 Apr 2024

    Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Heated respiratory humidifier
Model / Ref / Catalog
PT101USR
Primary DI / UDI-DI
10190752102484
510(k) Number
FDA Product Code
BTT
GMDN Term
Heated respiratory humidifier
Device Class
Class II
Regulation Number
868.5450
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K131895)

Show all (11)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No