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Monoject

FDA UDI

Class I (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Oral/enteral medicine medicated administration kit, single-use FDA UDI
Device Name
3 mL Oral Syringe,Amber FDA UDI
Model / Reference
8881903010 FDA UDI
Description
3 mL Oral Syringe,Amber FDA UDI

Identifiers

Catalog Number
8881903010 FDA UDI
Primary DI / UDI-DI
10884521014879 FDA UDI
FDA Product Code
KYW FDA UDI
GMDN Term
Oral/enteral medicine medicated administration kit, 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 3 Milliliter FDA UDI

Category: Oral/enteral medicine medicated administration kit, single-use

Monoject by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/enteral medicine medicated administration kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI b3914b86-7332-4537-8a1b-40a60d32a1c9 37 fields · synced May 31, 2026