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Neo-Tee T-Piece Resuscitator 10-50823

by Mercury Enterprises, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10641043508473 UDI-DIDate26 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0821-2025 FDA Class I initiated 10 Dec 2024

    Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

    • Ongoing Z-0004-2025 FDA Class I initiated 30 Aug 2024

    Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

    • Terminated Z-0639-2016 FDA Class II initiated 22 Oct 2015

    Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

Specification

GUDID

Trade Name
Neo-Tee T-Piece Resuscitator
Generic Name
Pulmonary resuscitator, manual, single-use
Model / Reference
10-50823
Primary DI / UDI-DI
10641043508473
510(k) Number
FDA Product Code
BTL
GMDN Term
Pulmonary resuscitator, manual, single-use
Device Class
Class II
Regulation Number
868.5925
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K093913)

Other devices from Mercury Enterprises, Inc.

See all devices from Mercury Enterprises, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No