enFlow 980121EU

GUDID 10885403296819

enFlow™ Controller Model 121

Carefusion Corporation

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 10885403296819
• NIH Device Record Key: 23fb6115-fc04-4c2d-8ad8-8acc48d66b21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enFlow
• Version Model Number: 980121EU
• Catalog Number: 980121EU
• Company DUNS: 830432451
• Company Name: Carefusion 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403296819 [Primary]

FDA Product Code

• LGZ: Warmer, thermal, infusion fluid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-03-22
• Device Publish Date: 2016-09-27

On-Brand Devices [enFlow]

• 50885403296886: enFlow™ Warmer Cord Clip
• 50885403296879: enFlow™ Warmer Holder
• 50885403296862: enFlow™ Insulated Warmer Strap
• 10885403296819: enFlow™ Controller Model 121
• 10885403296789: enFlow™ IV Fluid/Blood Warmer Model 100
• 10885403291319: enFlow™ Power Cord - US, Canada, Latin America
• 50885403286160: enFlow™ Disposable IV Fluid/Blood Warmer Cartridge With IV Extension Model 200
• 20885403286152: enFlow™ Disposable IV Fluid/Blood Warmer Cartridge Model 200