BD UniVia

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD UniVia FDA UDI
Generic Name: ENFit oral/enteral syringe, single-use FDA UDI
Device Name: SYRINGE ORAL 3ML CLEAR STERILE FDA UDI
Model / Reference: 305853 FDA UDI
Description: SYRINGE ORAL 3ML CLEAR STERILE FDA UDI

Identifiers

Catalog Number: 305853 FDA UDI
Primary DI / UDI-DI: 00382903058532 FDA UDI
510(k) Number: K112434 FDA UDI
FDA Product Code: KNT 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

Yes

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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 3 Milliliter FDA UDI

Category: ENFit oral/enteral syringe, single-use

BD UniVia by Becton Dickinson And Company — 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

K112434 also covers:

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: Becton Dickinson And Company

Sources (1)

FDA UDI 6d600877-91e3-4678-aac7-3ac409d5ef7b 36 fields · synced Jun 1, 2026