FDA.reportPublic FDA data

Cardiart TS6000 Premium Cardiology Stethoscope

Primary DI
04719874400088
Brand
Cardiart TS6000 Premium Cardiology Stethoscope
Company
IMEDIPLUS INC.
Model
TS6000 Premium
Device description
Cardiart TS6000 Premium Cardiology Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
Published
2019-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LDEStethoscope, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874400088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874400088047198744000884719874400088

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical external stethoscopeA non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height31.6Millimeter
Outer Diameter45Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658869745
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874400095Cardiart TS3000PD Pediartic Dual Head StethoscopeTS3000PD2019-09-03
04719874400101IMEDIPLUS TS-3000S Single Head StethoscopeTS-3000S2019-09-03
04719874400118IMEDIPLUS TS-3000D Dual Head StethoscopeTS-3000D2019-09-03
04719874400149IMEDIPLUS TS-3000S Single Head Stethoscope BlueTS-3000S Blue2020-06-23
04719874400156IMEDIPLUS TS-3000S Single Head Stethoscope BlackTS-3000S Black2020-06-23
04719874400163IMEDIPLUS TS-3000S Single Head Stethoscope Wine RedTS-3000S Wine Red2020-06-23
04719874400170IMEDIPLUS TS-3000D Dual Head Stethoscope BlueTS-3000D Blue2020-06-23
04719874400187IMEDIPLUS TS-3000D Dual Head Stethoscope BlackTS-3000D Black2020-06-23
04719874400194IMEDIPLUS TS-3000D Dual Head Stethoscope Wine RedTS-3000D Wine Red2020-06-23
04719874400200Cardiart TS6000 Premium Cardiology Stethoscope BlackTS6000 Premium Black2020-06-23
04719874400217Cardiart TS3000PD Pediartic Dual Head Stethoscope BlackTS3000PD Black2020-06-23
04719874400125Cardiart Dual Head Stethoscope TS3000DL (Double-lumen)TS3000DL2019-09-11
04719874400019Cardiart Electronic StethoscopeDS1012019-01-08
04719874400026Omni-Steth Electronic StethoscopeOmni-Steth2019-01-08
04719874400040IMEDIPLUS Electronic Stethoscope DS3011ADS3011AP2019-01-08

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