Product code OUG— General Hospital
T:CONNECT DATA MANAGEMENT SYSTEM
- Classification name
- Medical Device Data System
- Device class
- Class 1
- Regulation
- 21 CFR 880.6310
- Advisory panel
- General Hospital
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code OUG
FDA has cleared device under product code OUG, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code OUG
Adverse events under product code OUG
product code OUG- Malfunction
- 2,311
- Other
- 12
- Total
- 2,323
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OUG
Data sourced from openFDA. This site is unofficial and independent of the FDA.