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Nebulizer and Compressor ALIF014NEB100

by SUNSET HEALTHCARE SOLUTIONS, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848530107932 UDI-DIDate26 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

1 recall · FDA

    • Terminated Z-1058-2019 FDA Class II initiated 29 Aug 2018

    The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.

Specification

GUDID

Trade Name
Nebulizer and Compressor
Generic Name
Nebulizing system delivery set, single-use
Model / Reference
ALIF014NEB100
Primary DI / UDI-DI
00848530107932
510(k) Number
FDA Product Code
CAF
GMDN Term
Nebulizing system delivery set, single-use
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K091272)

Show all (12)

Other devices from SUNSET HEALTHCARE SOLUTIONS, Inc.

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Properties

  • Single Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No