GD 040-184-7100

GUDID 00862186000386

The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.

General Devices

Medical networking interface unit

• Primary Device ID: 00862186000386
• NIH Device Record Key: dc6990cb-70bd-4523-a2c3-2999d3c7e1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GD
• Version Model Number: Rosetta-Lt Data Translator
• Catalog Number: 040-184-7100
• Company DUNS: 101394815
• Company Name: General Devices
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862186000386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002089

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [GD]

• 00086186000331: The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the elect
• 00862186000386: The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators
• 00862186000379: The CAREpoint Workstation communication console is a standard radio/telephony communications con
• 00862186000362: The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the elect
• 00862186000355: The Prep-Check Plus, 50 pin is a hand-held, battery powered device intended to measure the elect
• 00862186000348: The Prep-Check Plus, 37 pin, is a hand-held, battery powered device intended to measure the ele
• 00862186000324: The Prep-Check Plus, 20 pin model is a hand-held, battery powered device intended to measure the
• 00862186000317: The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical im
• 00862186000300: The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical im
• 00862186000331: The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the elect