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Longfian JAY-5KW

by Longfian Scitech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06934726614316 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1815-2026 FDA Class II initiated 4 Feb 2026

    Devices which did not meet internal quality specifications were inadvertently distributed.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Longfian
Generic Name
Mobile/portable oxygen concentrator
Model / Reference
JAY-5KW
Primary DI / UDI-DI
06934726614316
510(k) Number
FDA Product Code
CAW
GMDN Term
Mobile/portable oxygen concentrator
Device Class
Class II
Regulation Number
868.5440
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Longfian Scitech Co., Ltd.

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No