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N/A 8912

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607411890178 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0108-2012 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
8912
Primary DI / UDI-DI
00607411890178
FDA Product Code
CCQ
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class I
Regulation Number
868.5640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Therapeutic agent nebulizer, benchtop

Cleared under the same submission (K870027)

Show all (12)

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No
  • Manufacturing Date: No