OUGClass I

Medical Device Data System

21 CFR 880.6310 / General Hospital

OUG is the FDA product code for Medical Device Data System, a class I device type, regulated under 21 CFR 880.6310. FDA's definition for this code reads: "A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2013-02-22, and 24 recalls.

Classification record

Product code: OUG
Device name: Medical Device Data System
FDA definition: A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
Regulation: 21 CFR 880.6310
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 24

Clearances, product code OUG

By decision year

1 clearance under product code OUG with a decision year between 2013 and 2013, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OUG by decision year
Year	Clearances
2013	1

Applicants with the most clearances

Product code OUG

Applicants holding the most 510(k) clearances under product code OUG
Applicant	Clearances
Tandem Diabetes Care, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 289 companies shown, in name order