FDA.reportPublic FDA data

GD

Primary DI
00862186000386
Brand
GD
Company
General Devices
Model
Rosetta-Lt Data Translator
Catalog number
040-184-7100
Device description
The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002089000ROSETTA-LT/ROSETTA-RXGeneral Devices2000-11-21DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862186000386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862186000386008621860003868621860003860862186000386

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101394815
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862186000379GDCAREpoint Workstation040-183-40002016-09-23
00862186000331GDPrep-Check Plus, 25 pinEIM-107-25B2020-04-02
00862186000300GDPrep-Check 10HzEIM-105-10Hz 2016-09-23
00862186000317GDPrep-Check 30HzEIM-105-30Hz2016-09-23
00862186000324GDPrep-Check Plus, 20 pinEIM 107-20A2016-09-23
00862186000348GDPrep-Check Plus, 37 pinEIM 107-37A2016-09-23
00862186000355GDPrep-Check Plus, 50 pinEIM-107-50B2016-09-23
00862186000362GDPrep-Check Plus, 68 pinEIM-107-68B2016-09-23
00086186000331GDPrep-Check Plus, 25 pinEIM-107-25B2016-09-23

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Primary DI, Brand, Company table
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