Identity
- Trade Name
- RxCrush EUDAMEDFDA UDI
- Generic Name
- Pill crusher/splitter FDA UDI
- Device Name
- Pill Pouch EUDAMEDRxCrush Pill Pouch, 2"x3", 30ml, ENFit. Pill Pouch with locking ENFit for pill crushing. FDA UDI
- Model / Reference
- PP08 Pill Pouch EUDAMEDPP08-50 FDA UDI
- Description
- RxCrush Pill Pouch, 2"x3", 30ml, ENFit. Pill Pouch with locking ENFit for pill crushing. FDA UDI
Identifiers
- Catalog Number
- PP08 FDA UDI
- Primary DI / UDI-DI
- 00850006611195 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850006611PP8C EUDAMED
- Direct Marketing DI
- 00850006611195 EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- A080199 NUTRITION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Pill crusher/splitter 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 | 0850006611PP8C | 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 481ad58a-1f8f-40fd-ba9f-09a3c3697a0f 61 fields · synced Jul 17, 2026
- FDA UDI 2990f4db-e976-453f-a98f-c64fa775d03d 36 fields · synced May 30, 2026