CENTRIMAG RVAS HDE KIT 104318

GUDID 07640135140603

Thoratec Switzerland GmbH

External ventricular circulatory assist system

• Primary Device ID: 07640135140603
• NIH Device Record Key: a2cf1e96-1b00-42a2-8b16-8eb162b4d7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTRIMAG RVAS HDE KIT
• Version Model Number: 104318
• Catalog Number: 104318
• Company DUNS: 486066918
• Company Name: Thoratec Switzerland GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640135140603 [Primary]

FDA Product Code

• OJE: Right Ventricular Bypass (Assist) Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-06
• Device Publish Date: 2014-09-20

Devices Manufactured by Thoratec Switzerland GmbH

• 07640135140276 - CentriMag™: 2022-04-06 Pressure Cable for BD DTX Plus Transducer
• 07640135140283 - CentriMag™: 2022-04-06 Centrimag Motor Bracket (45 degree)
• 07640135140412 - CentriMag™: 2022-04-06 Pressure Cable for Bbraun Combitrans Pressure Transducers
• 07640135140429 - CentriMag™: 2022-04-06 Pressure Cable for Smiths Medical TranStar Pressure Sensors
• 07640135140436 - CentriMag™: 2022-04-06 Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors
• 07640135140443 - CentriMag™: 2022-04-06 Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors
• 07640135140481 - CentriMag™: 2022-04-06 Pressure Cable for Argon Medical CDX III Pressure Transducers
• 07640135140566 - CentriMag™: 2022-04-06 USB Stick containing Mag Log Converter Software