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Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Peripheral intravenous catheterization kit, non-sensing FDA UDI
Device Name
Blunt Tip Needle,I.V. Access FDA UDI
Model / Reference
8881540101 FDA UDI
Description
Blunt Tip Needle,I.V. Access FDA UDI

Identifiers

Catalog Number
8881540101 FDA UDI
Primary DI / UDI-DI
10884521082915 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Peripheral intravenous catheterization kit, non-sensing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral intravenous catheterization kit, non-sensing

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

Similar devices

Also classified as Peripheral intravenous catheterization kit, non-sensing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI ef5f2d40-4d81-4147-8520-acd308e46d06 36 fields · synced May 30, 2026