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Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask 1055-E

by Unomedical, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

23 closed

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 Number00084424900573 UDI-DI Date15 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

23 recalls · FDA

  • 23 recalls, same reason

    • Terminated Z-0045-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0039-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0047-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0050-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0071-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0041-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0051-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0052-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0054-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0058-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0048-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0043-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0057-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0049-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0044-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0055-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0070-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0072-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0040-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0042-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0046-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0053-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009
    • Terminated Z-0056-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009

    In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask
Generic Name
Resuscitator face mask, single-use
Model / Ref / Catalog
1055-E
Primary DI / UDI-DI
00084424900573
510(k) Number
FDA Product Code
BTM
GMDN Term
Resuscitator face mask, single-use
Device Class
Class II
Regulation Number
868.5915
GUDID distribution status
Not in Commercial Distribution

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