Identity
- Trade Name
- Enteral Feeding FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, TwistLok/Adapter FDA UDI
- Model / Reference
- EB-060-18 FDA UDI
- Description
- Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, TwistLok/Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00020451100074 FDA UDI
- 510(k) Number
- K895367 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
No
FDA UDI
Category: Intravenous administration tubing extension set
Enteral Feeding by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K895367 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 |
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Manufacturer
- Manufacturer
- Medela LLC
Sources (1)
- FDA UDI 64112284-bcd3-4b7f-8d28-37d64397117f 35 fields · synced Jun 1, 2026