ENFit Syringe 1ml

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name: ENFit Syringe 1ml FDA UDI
Generic Name: ENFit oral/enteral syringe, single-use FDA UDI
Model / Reference: ENF01LD FDA UDI

Identifiers

Catalog Number: 101033159 FDA UDI
Primary DI / UDI-DI: 00020451101309 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 1ml 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 3ml — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medela LLC

Sources (1)

FDA UDI 4cce06d8-cadb-4c39-97f9-d18a69b4232e 35 fields · synced Jun 1, 2026