FDA.reportPublic FDA data

THORATEC RECHARGEABLE LI-ION BATTERY

Primary DI
07640135140535
Brand
THORATEC RECHARGEABLE LI-ION BATTERY
Company
Thoratec Switzerland GmbH
Model
201-50207
Catalog number
201-50207
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
07640135140535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140535076401351405357640135140535

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure79.3 KiloPascal101.3 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
Expiration date on label
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
07640135140696Mag Monitor Set201-90404201-904042014-09-20
07640135140399TUBING BEND RELIEF201-50126201-501262014-09-20
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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