FDA.reportPublic FDA data

Mag Monitor Set

Primary DI
07640135140696
Brand
Mag Monitor Set
Company
Thoratec Switzerland GmbH
Model
201-90404
Catalog number
201-90404
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640135140696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140696076401351406967640135140696

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70.2 KiloPascal110 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
486066918
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640135140351CENTRIMAG™ TRAINING LOOP1029631029632014-09-20
07640135140405METAL LOCKING FEATURE FOR CENTRIMAG MOTOR1043261043262014-09-20
07640135140498CentriMag Pressure Cable for BD DTX Plus Transducer1043031043032014-09-20
07640135140771CENTRIMAG™ System Transporter201-50140201-501402014-09-20
07640135140603CENTRIMAG RVAS HDE KIT1043181043182014-09-20
07640135140320CONSOLE STANDOFF1043051043052014-09-20
07640135140559CONSOLE STANDOFF DISTANCE HOLDER201-52009201-520092014-09-20
07640135140788CIRCULAR OXYGENATOR BRACKET SMALL201-50141201-501412014-09-20
07640135140795CIRCULAR OXYGENATOR BRACKET MEDIUM201-50142201-501422014-09-20
07640135140801CIRCULAR OXYGENATOR BRACKET LARGE201-50143201-501432014-09-20
07640135140818SQUARE OXYGENATOR BRACKET201-50144201-501442014-09-20
07640135140184CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT201-50067201-500672014-09-20
07640135140191CENTRIMAG® 24FR RETURN CANNULA KIT201-50068201-500682014-09-20
07640135140399TUBING BEND RELIEF201-50126201-501262014-09-20
07640135140535THORATEC RECHARGEABLE LI-ION BATTERY201-50207201-502072014-09-20
07640135140542INTERNAL RECHARGEABLE NIMH BATTERY PACK FOR CENTRIMAG PRIMARY CONSOLE1041721041722014-09-20
07640135140627CentriMag™1029531029532014-09-20
07640135140276CentriMag™201-50110201-501102022-03-29
07640135140412CentriMag™201-50128201-501282022-03-29
07640135140429CentriMag™201-50129201-501292022-03-29

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Primary DI, Brand, Company table
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