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Powered breast pump imani i2Plus Pro

by Imani Co. 3 variants

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 Number08800051100634 UDI-DI Date3 Dec 2025ListedStatusListed 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  • Withdrawn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
Powered breast pump
Generic Name
Breast pump, electric
Model / Reference
imani i2Plus Pro
Primary DI / UDI-DI
08800051100634
510(k) Number
FDA Product Code
HGX
GMDN Term
Breast pump, electric
Device Class
Class II
Regulation Number
884.5160
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K222573)

Other devices from Imani Co.

See all devices from Imani Co. →

Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No