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DIRECT2 Lid PVL/PURE2

by Bimini Technologies LLC

DIRECT2 Lid PVL/PURE2 is a Class I device made by Bimini Technologies LLC, listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00850034511993), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850034511993 UDI-DI Date4 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
DIRECT2 Lid
Generic name
Surgical suction system collection container, reusable
Model / reference
PVL/PURE2
Primary DI / UDI-DI
00850034511993
FDA product code
MDM
GMDN term
Surgical suction system collection container, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)