← Back to catalogue

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
1 mL Oral Syringe,Amber FDA UDI
Model / Reference
8881901006 FDA UDI
Description
1 mL Oral Syringe,Amber FDA UDI

Identifiers

Catalog Number
8881901006 FDA UDI
Primary DI / UDI-DI
10884521015104 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 — 1 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 7d2c6b84-52b5-4c16-b6fd-f8bd9f5ed13d 37 fields · synced May 30, 2026