REMOVABLE HARD DRIVES
N/A - 9204
Device Description
A mains electricity (AC-powered), electronic, device designed to receive and store both image and sound on a magnetic video tape (a standard video cassette) as electronic signals. During recording, the inputs of the recorder's electronic circuitry and recording heads are connected to a video signal source (e.g., video or television camera). The information is retrieved through playback heads (that typically are an integral part of the recorder), and the output is connected to an appropriate monitor or is fed into another device for further manipulation. This is a general-purpose recording/playback device and is commonly called a VCR (video cassette recorder).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OUG
Device Name: Medical Device Data System
Device Class: 1
Physical State: Software and Electronics
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.
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Software algorithms to perform necessary medical communication functions
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Hospital Information Systems
Regulation Number: 880.6310
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 04961333240661
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A