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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
General-purpose syringe, single-use FDA UDI
Device Name
Blunt Cannula FDA UDI
Model / Reference
8881202363 FDA UDI
Description
Blunt Cannula FDA UDI

Identifiers

Catalog Number
8881202363 FDA UDI
Primary DI / UDI-DI
20192253036920 FDA UDI
FDA Product Code
GAA FDA UDI
GMDN Term
General-purpose syringe, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 20 Gauge FDA UDI
Length — 1.5 Inch FDA UDI

Category: General-purpose syringe, single-use

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

Similar devices

Also classified as General-purpose syringe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 58a2fc0f-a7e7-4c8c-8e0c-fd1a621cd888 35 fields · synced Jun 8, 2026