Trinity Sterile, Inc. 50235

by Trinity Sterile, Inc.

Trinity Sterile, Inc. 50235 is a Class II device made by Trinity Sterile, Inc., cleared under FDA 510(k) K923361 on 28 Jun 1993 and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 10841767103842), 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	Number10841767103842 UDI-DI	Date27 Jul 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SEKD from GUDID Traditional	NumberK923361	Date28 Jun 1993Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10841767103842
FDA 510(k) database 510(k) number K923361

Across registries

2 registries list this device

FDA 510(k) K923361 decided 28 Jun 1993 Active
FDA GUDID UDI-DI 10841767103842 listed 27 Jul 2023 Listed

Timeline

2 dated events

28 Jun 1993 Cleared FDA 510(k) K923361
27 Jul 2023 Listed FDA GUDID 10841767103842

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Trinity Sterile, Inc.
Generic name: Basic intravenous administration set, noninvasive
Model / reference: 50235

Primary DI / UDI-DI: 10841767103842
510(k) Number: K923361
FDA product code: LRS
GMDN term: Basic intravenous administration set, noninvasive

Device class: Class II
Regulation number: 880.5200
GUDID distribution status: In Commercial Distribution

Other devices from Trinity Sterile, Inc.

See all devices from Trinity Sterile, Inc. →

Properties

Supplied sterile
Single use
Convenience kit
Lot / batch number
Serial number

Other properties (10, all answered No)