CAPIOX®FX

GUDID 04987350701107

FX15

TERUMO CORPORATION

Extracorporeal membrane oxygenator

• Primary Device ID: 04987350701107
• NIH Device Record Key: d7b4d387-3873-4bb5-9451-2ef1ca2a553e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPIOX®FX
• Version Model Number: CX*FX15RE40
• 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: cvscustomerservice@terumomedical.com

Device Dimensions

• Area/Surface Area: 1.5 Square meter

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987350701107 [Primary]

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-09-15

On-Brand Devices [CAPIOX®FX]

• 04987350781772: FX05
• 04987350781758: FX05
• 04987350781734: FX05
• 04987350781710: FX05
• 04987350701206: FX15
• 04987350701183: FX15
• 04987350701169: FX15
• 04987350701145: FX15
• 04987350701121: FX15
• 04987350701107: FX15
• 04987350701084: FX25
• 04987350701060: FX25
• 04987350701046: FX25
• 04987350701022: FX25