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N/A 8900-14

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 Number00607411000737 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  • Withdrawn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
8900-14
Primary DI / UDI-DI
00607411000737
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