McKesson

FDA UDI

Class I (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: McKesson FDA UDI
Generic Name: ENFit oral/enteral syringe, single-use FDA UDI
Device Name: Syringe Irrigation Flat Tip Piston Catheter Tip FDA UDI
Model / Reference: 904 FDA UDI
Description: Syringe Irrigation Flat Tip Piston Catheter Tip FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479201863 FDA UDI
FDA Product Code: KYZ FDA UDI
GMDN Term: ENFit oral/enteral syringe, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6960 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: ENFit oral/enteral syringe, single-use

McKesson by Mckesson Medical-Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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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: Mckesson Medical-Surgical Inc.

Sources (1)

FDA UDI c8b74733-4382-4ae2-8bfc-a991b00c7b0a 33 fields · synced Jun 8, 2026