Identity
- Trade Name
- ENFit Extension Set FDA UDI
- Generic Name
- Nasoenteral tube FDA UDI
- Device Name
- 48" Enteral Ext Set Large Bore Orange FDA UDI
- Model / Reference
- NM-48ENENB FDA UDI
- Description
- 48" Enteral Ext Set Large Bore Orange FDA UDI
Identifiers
- Catalog Number
- NM-48ENENB FDA UDI
- Primary DI / UDI-DI
- 00350770001951 FDA UDI
- 510(k) Number
- K100288 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Nasoenteral tube 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
Yes
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
Category: Nasoenteral tube
ENFit Extension Set by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasoenteral tube.
- NeoConnect Enteral Feeding Tube — NEOMED, INC. · Class II
- NutraGlide Nasal Feeding Tube — Applied Medical Technology, Inc. · Class II
- Argyle — Cardinalhealth · Class II
- NeoConnect Enteral Feeding Tube — NEOMED, INC. · Class II
- NeoConnect Enteral Extension Set — NEOMED, INC. · Class II
- NeoMed Enteral Feeding Tube — NEOMED, INC. · Class II
- NeoMed Enteral Feeding Tube — NEOMED, INC. · Class II
- NeoConnect Enteral Extension Set — NEOMED, INC. · Class II
Cleared under the same submission
K100288 also covers:
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
- ENFit Extension Set — Avanos Medical, Inc.
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI e079f6b0-6a3f-4df7-832d-33a58e671f78 36 fields · synced Jun 9, 2026