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Single Use Infant 280ml Resuscitator W/ Pop-Off 40cm H2O, L Type Adapter with Man Re-24622

by Besmed Health Business Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04716770246222 UDI-DI Date28 Dec 2017ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Single Use Infant 280ml Resuscitator W/ Pop-Off 40cm H2O,L Type Adapter with Man
Generic Name
Pulmonary resuscitator, manual, single-use
Model / Reference
RE-24622
Primary DI / UDI-DI
04716770246222
510(k) Number
FDA Product Code
BTM
GMDN Term
Pulmonary resuscitator, manual, single-use
Device Class
Class II
Regulation Number
868.5915
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary resuscitator, manual, single-use

Cleared under the same submission (K021442)

Show all (12)

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Properties

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

Other properties (9)

  • 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