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Promethean Island 4400

by M D Technologies, Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB325PI44001 UDI-DIDate5 Aug 2022ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Promethean
Generic Name
Absorbent underpad, non-antimicrobial, single-use
Model / Ref / Catalog
Island 4400, PI4400
Primary DI / UDI-DI
B325PI44001
FDA Product Code
FLH
GMDN Term
Absorbent underpad, non-antimicrobial, single-use
Device Class
Class I
Regulation Number
880.6800
Commercial Distribution
Not in Commercial Distribution

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt

Other properties (11)

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