BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

enFlow

DI: 10885403296819 · Model: 980121EU · Carefusion Corporation

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: enFlow
Primary DI: 10885403296819
Version / Model: 980121EU
Catalog Number: 980121EU
Company Name: Carefusion Corporation
Labeler DUNS: 830432451
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-27
Public Version: 4
Public Version Date: 2024-05-21
Public Version Status: Update
Public Device Record Key: 23fb6115-fc04-4c2d-8ad8-8acc48d66b21
Distribution End Date: 2022-03-31

Device Description

enFlow™ Controller Model 121

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGZ	Warmer, thermal, infusion fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47616	Conduction blood/fluid warmer	An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885403296819	GS1

Customer Contacts

Phone: +1(800)323-9088
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -30 – 70 Degrees Celsius