FDA.reportPublic FDA data

CENTRIMAG RVAS HDE KIT

Primary DI
07640135140603
Brand
CENTRIMAG RVAS HDE KIT
Company
Thoratec Switzerland GmbH
Model
104318
Catalog number
104318
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJERight Ventricular Bypass (Assist) Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJERight Ventricular Bypass (Assist) DeviceUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640135140603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140603076401351406037640135140603

GMDN Terms#

Term, Definition table
TermDefinition
External ventricular circulatory assist systemAn assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a mains electricity (AC-powered) external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 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
Expiration 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
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
07640135140467PEDIATRIC TRAINING LOOP201-50134201-501342014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640135140153CentriMag™Thoratec CorporationOJE2026-02-19
00813502011029ImpellaAbiomed, Inc.OJE2016-01-20