Identity
- Trade Name
- EcoFLX™ Empty Mixing Container FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- EcoFLX 250mL Empty IV Mixing Container with 1 Spike Lead (EVA) FDA UDI
- Model / Reference
- DME0251 FDA UDI
- Description
- EcoFLX 250mL Empty IV Mixing Container with 1 Spike Lead (EVA) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816415020567 FDA UDI
- 510(k) Number
- K932640 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous administration bag/bottle
EcoFLX™ Empty Mixing Container by Douglas Medical Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K932640 also covers:
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
- EcoFLX™ Empty Mixing Container — DOUGLAS MEDICAL PRODUCTS, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Douglas Medical Products, Inc
Sources (1)
- FDA UDI d00bbc88-4041-4de5-a3cd-cd0a938a3c20 34 fields · synced Jun 1, 2026