Identity
- Trade Name
- ENFit Syringe FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- 3mL ENFit Syringe Purp Sterile FDA UDI
- Model / Reference
- PNM-S3NC FDA UDI
- Description
- 3mL ENFit Syringe Purp Sterile FDA UDI
Identifiers
- Catalog Number
- PNM-S3NC FDA UDI
- Primary DI / UDI-DI
- 00350770001074 FDA UDI
- 510(k) Number
- K161039 FDA UDI
- FDA Product Code
- PNR FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use 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: ENFit oral/enteral syringe, single-use
ENFit Syringe by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit oral/enteral syringe, single-use.
- NeoMed Oral / Enteral Syringe — NEOMED, INC. · Class II
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- NeoBottle — NEOMED, INC. · Class I
- EXACTAMED — Baxter Healthcare Corp · Class I
- Health Care Logistics, Inc® — Health Care Logistics · Class I
- Ameritus Oral Syringe — KENTEC MEDICAL, INC. · Class I
- VYGON — Vygon Corp. · Class II
- BD UniVia — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K161039 also covers:
- 20mL ENFit GPro Syringe Purple Sterile — Avanos Medical, Inc.
- Baxter Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- Baxter Sterile Enteral Syringe with ENFit® Connector — Avanos Medical, Inc.
- ENFit Syringe — 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 af435b42-e141-4e67-8f61-c440f7aeb90e 36 fields · synced Jun 9, 2026