ENFit Syringe 3ml

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name: ENFit Syringe 3ml FDA UDI
Generic Name: ENFit oral/enteral syringe, single-use FDA UDI
Model / Reference: ENF03LD FDA UDI

Identifiers

Catalog Number: 101033160 FDA UDI
Primary DI / UDI-DI: 00020451101323 FDA UDI
510(k) Number: K161811 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ENFit oral/enteral syringe, single-use

ENFit Syringe 3ml by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENFit oral/enteral syringe, single-use.

ENFit Syringe — Avanos Medical, Inc. · Class II
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

Cleared under the same submission

K161811 also covers:

ENFit Syringe 1ml — 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 77f697a2-c082-4a6a-a0b6-171d6115c9b9 34 fields · synced Jun 6, 2026