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Aerogen® Go 00USA86C0004

by Hcmed Innovations 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 Number04719873130351 UDI-DI Date28 Jan 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  • Withdrawn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
Aerogen® Go
Generic Name
Noninvasive device battery charger
Model / Reference
00USA86C0004
Primary DI / UDI-DI
04719873130351
510(k) Number
FDA Product Code
CAF
GMDN Term
Noninvasive device battery charger
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K202171)

Other devices from Hcmed Innovations Co., Ltd.

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