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Salter Labs® Full Kit Nebulizer 13951

by Salter Labs, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number00607411919350 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2781-2015 FDA Class II initiated 4 Aug 2015

    The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Salter Labs® Full Kit Nebulizer
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Reference
13951
Primary DI / UDI-DI
00607411919350
510(k) Number
FDA Product Code
CAF
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K961476)

Show all (12)

Other devices from Salter Labs, LLC

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Properties

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

Other properties (8)

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