Medex MX920NF

by ICU Medical, Inc.

Medex MX920NF is a Class I device made by ICU Medical, Inc., cleared under FDA 510(k) K070340 on 15 Mar 2007 and listed in FDA GUDID since 13 Jan 2020 (UDI-DI 10351688504234), 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	Number10351688504234 UDI-DI	Date13 Jan 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK070340	Date15 Mar 2007Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10351688504234
FDA 510(k) database 510(k) number K070340

Across registries

2 registries list this device

FDA 510(k) K070340 decided 15 Mar 2007 Active
FDA GUDID UDI-DI 10351688504234 listed 13 Jan 2020 Listed

Timeline

2 dated events

15 Mar 2007 Cleared FDA 510(k) K070340
13 Jan 2020 Listed FDA GUDID 10351688504234

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Medex
Generic name: Luer-ended blood collection tube spike
Model / reference: MX920NF

Primary DI / UDI-DI: 10351688504234
510(k) Number: K070340
FDA product code: CBT
GMDN term: Luer-ended blood collection tube spike

Device class: Class I
Regulation number: 868.1100
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)