Identity
- Trade Name
- Enteral Feeding FDA UDI
- Generic Name
- ENFit/non-ISO80369-standardized linear connector FDA UDI
- Device Name
- Dual Cap, ENFit, Low Dose FDA UDI
- Model / Reference
- ENFDUALCAPLD FDA UDI
- Description
- Dual Cap, ENFit, Low Dose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00020451101415 FDA UDI
- 510(k) Number
- K894206 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- ENFit/non-ISO80369-standardized linear connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
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
Yes
FDA UDI
Category: ENFit/non-ISO80369-standardized linear connector
Enteral Feeding by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
Cleared under the same submission
K894206 also covers:
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
- Enteral Feeding — Medela LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medela LLC
Sources (1)
- FDA UDI 9fc5c810-851c-4169-b9d2-05da950d76db 35 fields · synced Jun 8, 2026