Identity
- Trade Name
- E3005OD EUDAMEDEXACTAMIX FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- IV Bags EUDAMED500 mL Exacatmix Empty EVA bag FDA UDI
- Model / Reference
- 5030050016 EUDAMEDE3005OD FDA UDI
- Description
- 500 mL Exacatmix Empty EVA bag FDA UDI
Identifiers
- Catalog Number
- 5030050016 FDA UDI
- Primary DI / UDI-DI
- 08033718000910 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033718IB007LT EUDAMED
- FDA Product Code
- KPE FDA UDI
- EMDN Code
- A080102 PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE EUDAMED
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Exactamix by Haemotronic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Haemotronic, Inc.
Sources (2)
- FDA UDI 2cfe483c-5d06-405b-9790-6691b4de7ddf 34 fields · synced Jun 19, 2026
- EUDAMED 23beaace-2d03-4217-ae05-abfeb468cde2 61 fields · synced Jun 14, 2026