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HarveyMed V6

by Shenzhen Harveymed Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number06975247360078 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HarveyMed
Generic Name
Mobile/portable oxygen concentrator
Model / Reference
V6
Primary DI / UDI-DI
06975247360078
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

Related devices

Cleared under the same submission (K252268)

Other devices from Shenzhen Harveymed Technology Co., Ltd.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: 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