Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
- Device Name
- ENTRAFLO H20 ENFIT SPIKE SET FDA UDI
- Model / Reference
- ENFIT70555 FDA UDI
- Description
- ENTRAFLO H20 ENFIT SPIKE SET FDA UDI
Identifiers
- Catalog Number
- ENFIT70555 FDA UDI
- Primary DI / UDI-DI
- 10888277410510 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 1000 Milliliter FDA UDI
Category: Enteral feeding kit, adult/paediatric, non-sterile
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Enteral feeding kit, adult/paediatric, non-sterile.
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- Plum — Hospira, Inc. · Class II
- Enteral Administration Kit, 1200mL Bag with Enfit® and transition connector — AMSINO INTERNATIONAL, INC. · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 3325838d-6ecf-4d2a-b10a-0dcce2319656 37 fields · synced May 30, 2026