Medex BBF26DTL

by ICU Medical, Inc.

Medex BBF26DTL 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 10351688512000), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10351688512000 UDI-DI	Date11 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK841882	Date5 Jun 1984Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10351688512000
FDA 510(k) database 510(k) number K841882

Across registries

2 registries list this device

FDA 510(k) K841882 decided 5 Jun 1984 Active
FDA GUDID UDI-DI 10351688512000 listed 11 Oct 2016 Listed

Timeline

2 dated events

5 Jun 1984 Cleared FDA 510(k) K841882
11 Oct 2016 Listed FDA GUDID 10351688512000

Coverage

1 jurisdiction

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Withdrawn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: BBF26DTL

Primary DI / UDI-DI: 10351688512000
510(k) Number: K841882
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

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)