Kbmed

FDA UDI

Class I (US FDA UDI)

by KB Medical (group), Inc.

Identity

Trade Name: KBMED FDA UDI
Generic Name: ENFit oral/enteral syringe, single-use FDA UDI
Device Name: ORAL DISPENSER 5ML WITHOUT CAP, BULK FDA UDI
Model / Reference: ORS2-5-CB2 FDA UDI
Description: ORAL DISPENSER 5ML WITHOUT CAP, BULK FDA UDI

Identifiers

Primary DI / UDI-DI: 00850016172273 FDA UDI
FDA Product Code: KYX FDA UDI
GMDN Term: ENFit oral/enteral syringe, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6430 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Kbmed by KB Medical (group), Inc. — Class I — 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

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 I	Pending data

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Manufacturer

Manufacturer: KB Medical (group), Inc.

Sources (1)

FDA UDI cb149911-e18c-4b2c-a289-7658c0fce085 33 fields · synced Jun 6, 2026