MediChoice IVS1021

by Owens & Minor Distribution, Inc.

MediChoice IVS1021 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K923361 on 28 Jun 1993 and listed in FDA GUDID since 12 Oct 2020 (UDI-DI 10885632113383), 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	Number10885632113383 UDI-DI	Date12 Oct 2020Listed	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 10885632113383
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 10885632113383 listed 12 Oct 2020 Listed

Timeline

2 dated events

28 Jun 1993 Cleared FDA 510(k) K923361
12 Oct 2020 Listed FDA GUDID 10885632113383

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MediChoice
Generic name: Peripheral intravenous catheterization support kit
Model / reference: IVS1021

Primary DI / UDI-DI: 10885632113383
510(k) Number: K923361
FDA product code: LRS
GMDN term: Peripheral intravenous catheterization support kit

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

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

Supplied sterile
Single use
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (9, all answered No)