EcoFLX™ Empty Mixing Container

GUDID 10816415020376

EcoFLX 500mL Empty IV Mixing Container (EVA)

DOUGLAS MEDICAL PRODUCTS, INC.

Intravenous administration bag/bottle

• Primary Device ID: 10816415020376
• NIH Device Record Key: 5f729cf3-200c-4d6e-bbd2-cebe59398412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFLX™ Empty Mixing Container
• Version Model Number: DME0500
• Company DUNS: 121040922
• Company Name: DOUGLAS MEDICAL PRODUCTS, INC.
• Device Count: 60
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816415020379 [Unit of Use]
GS1	10816415020376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932640

FDA Product Code

• KPE: Container, I.V.

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: 2019-10-23
• Device Publish Date: 2018-05-06

On-Brand Devices [EcoFLX™ Empty Mixing Container]

• 10816415020697: EcoFLX 5000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020680: EcoFLX 4000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020673: EcoFLX 3000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020666: EcoFLX 2000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020659: EcoFLX 1000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020574: EcoFLX 500mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020567: EcoFLX 250mL Empty IV Mixing Container with 1 Spike Lead (EVA)
• 10816415020550: EcoFLX 1000mL Empty IV Mixing Container (EVA)
• 10816415020543: EcoFLX 1000mL Empty IV Mixing Container (PVC-Free)
• 10816415020536: EcoFLX 500mL Empty IV Mixing Container (PVC-Free)
• 10816415020529: EcoFLX 100mL Empty IV Mixing Container (PVC-Free)
• 10816415020512: EcoFLX 5000mL Empty IV Mixing Container (EVA)
• 10816415020505: EcoFLX 4000mL Empty IV Mixing Container (EVA)
• 10816415020499: EcoFLX 3000mL Empty IV Mixing Container (EVA)
• 10816415020482: EcoFLX 2000mL Empty IV Mixing Container (EVA)
• 10816415020475: EcoFLX 5000mL Empty IV Mixing Container (PVC-Free)
• 10816415020468: EcoFLX 3000mL Empty IV Mixing Container (PVC-Free)
• 10816415020437: EcoFLX 150mL Empty IV Mixing Container (PVC-Free)
• 10816415020376: EcoFLX 500mL Empty IV Mixing Container (EVA)
• 10816415020369: EcoFLX 250mL Empty IV Mixing Container (EVA)
• 10816415020352: EcoFLX 2000mL Empty IV Mixing Container (PVC-Free)
• 10816415020321: EcoFLX 250mL Empty IV Mixing Container (PVC-Free)