EcoFLX™ Empty Mixing Container

Basic Information

• Brand Name: EcoFLX™ Empty Mixing Container
• Primary DI: 10816415020697
• Version / Model: DME5001
• Company Name: DOUGLAS MEDICAL PRODUCTS, INC.
• Labeler DUNS: 121040922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2018-05-09
• Public Version: 3
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 0c8a653e-2cfa-44c7-b8c3-cd4c53d1a550

Device Description

EcoFLX 5000mL Empty IV Mixing Container with 1 Spike Lead (EVA)

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPE	Container, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816415020697	GS1
Unit of Use	00816415020690	GS1

Premarket Submissions

Submission Number	Supplement Number
K932640	000