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Monoject

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Monoject FDA UDI
Generic Name
Oral/enteral syringe drawing-up straw FDA UDI
Device Name
Monoject Medicine Straw with ENFit Connection FDA UDI
Model / Reference
462000E FDA UDI
Description
Monoject Medicine Straw with ENFit Connection FDA UDI

Identifiers

Catalog Number
462000E FDA UDI
Primary DI / UDI-DI
10192253008081 FDA UDI
FDA Product Code
KYX FDA UDI
GMDN Term
Oral/enteral syringe drawing-up straw 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/enteral syringe drawing-up straw

Monoject by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/enteral syringe drawing-up straw.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI af4ffc62-9a10-4e83-9d6f-665c229ec90f 34 fields · synced Jun 8, 2026