FDA.reportPublic FDA data

EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE

Primary DI
07640135140115
Brand
EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE
Company
Thoratec Switzerland GmbH
Model
201-30107
Catalog number
201-30107
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
07640135140115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140115076401351401157640135140115

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal fluid flow probeAn electronic device intended to be used to measure rate of fluid flow in an extracorporeal perfusion system tube using ultrasound transit time technology. It typically clamps over the exterior of a flexible tube and is used in conjunction with a flowmeter/flowmeter board incorporated into the perfusion system. This is a reusable device.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640135140184CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT201-50067201-500672014-09-20
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
07640135140191CENTRIMAG® 24FR RETURN CANNULA KIT201-50068201-500682014-09-20
07640135140696Mag Monitor Set201-90404201-904042014-09-20
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
07640135140634PEDIMAG BLOOD PUMP201-90052201-900522014-09-20
07640135140825CMAG TRANSPORTER, SPARE PART KIT 201-50147201-501472014-09-20

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