# Medical Device Data System
> **Product code: OUG** · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6310
## Classification
- **FDA Product Code:** OUG
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 880.6310
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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 data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 301
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OUG)
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