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Medex BF100

by ICU Medical, Inc.

Medex BF100 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K841882 on 5 Jun 1984 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688511980), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K841882

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688511980 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK841882 Date5 Jun 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K841882 decided 5 Jun 1984 Active
  • FDA GUDID UDI-DI 10351688511980 listed 11 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K841882
  2. Listed FDA GUDID 10351688511980

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medex
Generic name
Electric infusion pump administration set, single-use
Model / reference
BF100
Primary DI / UDI-DI
10351688511980
510(k) Number
FDA product code
FPA
GMDN term
Electric infusion pump administration set, single-use
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FPA (Set, administration, intravascular).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)