EcoFLX™ Empty Mixing Container
GUDID 10816415020697
EcoFLX 5000mL Empty IV Mixing Container with 1 Spike Lead (EVA)
DOUGLAS MEDICAL PRODUCTS, INC.
Intravenous administration bag/bottle| Primary Device ID | 10816415020697 |
| NIH Device Record Key | 0c8a653e-2cfa-44c7-b8c3-cd4c53d1a550 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EcoFLX™ Empty Mixing Container |
| Version Model Number | DME5001 |
| Company DUNS | 121040922 |
| Company Name | DOUGLAS MEDICAL PRODUCTS, INC. |
| Device Count | 40 |
| 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 | 00816415020690 [Unit of Use] |
| GS1 | 10816415020697 [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 | 2018-05-09 |
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) |
Trademark Results [EcoFLX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECOFLX 87797375 5829646 Live/Registered |
Douglas Medical Products, Inc 2018-02-14 |
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