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RxCrush
EUDAMEDFDA UDIClass I (EU MDR)
Ref EO02 ENFit® to Oral Adapter - Standard
Identity
- Trade Name
- RxCrush EUDAMEDFDA UDI
- Generic Name
- ENFit/non-ISO80369-standardized linear connector FDA UDI
- Device Name
- ENFit Adapter EUDAMEDENFit to Oral Adapter - Standard. Connects male ENFit (e.g. RxCrush Pouch) to male Oral syringe. FDA UDI
- Model / Reference
- EO02 ENFit® to Oral Adapter - Standard EUDAMEDEO02-100 FDA UDI
- Description
- ENFit to Oral Adapter - Standard. Connects male ENFit (e.g. RxCrush Pouch) to male Oral syringe. FDA UDI
Identifiers
- Catalog Number
- EO02 FDA UDI
- Primary DI / UDI-DI
- 00850006611140 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850006611AD67 EUDAMED
- Direct Marketing DI
- 00850006611140 EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- A088099 NUTRITION AND INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- ENFit/non-ISO80369-standardized linear connector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RxCrush by Resolve Designs LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850006611AD67 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Resolve Designs LLC
- EUDAMED SRN
- US-MF-000017382
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED ed45dfc1-bcf9-4302-95bb-b048873644a2 61 fields · synced Jun 8, 2026
- FDA UDI 069ec646-a6ab-4a65-bf53-0335c8453eb6 36 fields · synced May 30, 2026