CAPIOX CX*FX05REA

GUDID 04987350739063

CAPIOX FX Oxygenator

TERUMO CORPORATION

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 04987350739063
• NIH Device Record Key: 493baa2a-5113-4db8-8c6c-77c2c687fea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPIOX
• Version Model Number: CX*FX05REA
• Catalog Number: CX*FX05REA
• Company DUNS: 690543319
• Company Name: TERUMO CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx
• Phone: +1(800)521-2818
• Email: xxx@xx.xx

Device Dimensions

• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter
• Area/Surface Area: 0.5 Square meter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987350739063 [Primary]

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-14
• Device Publish Date: 2021-07-06

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