Identity
- Trade Name
- RxCrush FDA UDI
- Generic Name
- ENFit/non-ISO80369-standardized linear connector FDA UDI
- Device Name
- ENFit Transition Adapter. Connects female ENFit syringes to older style/legacy feeding tubes. FDA UDI
- Model / Reference
- ET01-100 FDA UDI
- Description
- ENFit Transition Adapter. Connects female ENFit syringes to older style/legacy feeding tubes. FDA UDI
Identifiers
- Catalog Number
- ET01 FDA UDI
- Primary DI / UDI-DI
- 00850006611157 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- ENFit/non-ISO80369-standardized linear connector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: ENFit/non-ISO80369-standardized linear connector
RxCrush by Resolve Designs LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit/non-ISO80369-standardized linear connector.
- Enteral Feeding — Medela LLC · Class II
- Y-Port Feeding Adapter — Applied Medical Technology, Inc. · Class II
- EnsoETM — Advanced Cooling Therapy, LLC · Class I
- Y-Port Feeding Adapter — Applied Medical Technology, Inc. · Class II
- Kangaroo — Cardinalhealth · Class II
- ENFit Transition Adapter — Applied Medical Technology, Inc. · Class II
- ENFit Transition Adapter — Applied Medical Technology, Inc. · Class II
- EnsoETM — Advanced Cooling Therapy, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Resolve Designs LLC
Sources (1)
- FDA UDI ec380ea5-00c1-4604-8085-9706ee3ae991 36 fields · synced Jun 8, 2026