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None Dsprlnkit-M-5

by Neurovision Medical Products Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810155862664 UDI-DIDate19 Dec 2025ListedStatusIn 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

10 recalls · 1 ongoing · FDA

    • Ongoing Z-2719-2024 FDA Class II initiated 1 Jul 2024

    mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

  • 9 recalls, same reason

    • Terminated Z-2900-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2905-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2904-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2907-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2903-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2901-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2906-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2902-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2908-2020 FDA Class II initiated 21 Jul 2020

    The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.

Specification

GUDID

Trade Name
None
Generic Name
Electromyographic endotracheal tube
Model / Ref / Catalog
DSPRLNKIT-M-5
Primary DI / UDI-DI
00810155862664
510(k) Number
FDA Product Code
ETN, BTR, GWF
GMDN Term
Electromyographic endotracheal tube
Device Class
Class II
Regulation Number
874.1820, 868.5730, 882.1870
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K110989)

Show all (12)

Other devices from Neurovision Medical Products Inc.

See all devices from Neurovision Medical Products Inc. →

Properties

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

Other properties (10)

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