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AeroForm® Dosage Controller V1.5

by Airxpanders, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10851452007157 UDI-DI Date21 Jun 2017ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AeroForm® Dosage Controller
Generic Name
Remotely-controlled tissue expander remote control
Model / Ref / Catalog
V1.5, AF-DC-1
Primary DI / UDI-DI
10851452007157
FDA Product Code
PQN
GMDN Term
Remotely-controlled tissue expander remote control
Device Class
Class II
Regulation Number
878.3510
GUDID distribution status
In Commercial Distribution

Related devices

Category: Remotely-controlled tissue expander remote control

Other devices from Airxpanders, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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