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Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Medicine preparation needle/cannula, sterile FDA UDI
Device Name
Vial Access Combo,Blunt Tip FDA UDI
Model / Reference
8881541604 FDA UDI
Description
Vial Access Combo,Blunt Tip FDA UDI

Identifiers

Catalog Number
8881541604 FDA UDI
Primary DI / UDI-DI
10884521124974 FDA UDI
510(k) Number
K980062 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Medicine preparation needle/cannula, sterile 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 6 Milliliter FDA UDI

Category: Medicine preparation needle/cannula, sterile

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

Similar devices

Also classified as Medicine preparation needle/cannula, sterile.

Cleared under the same submission

K980062 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI fb2904fa-6c93-4066-9bdc-00a70b594e4b 38 fields · synced Jun 1, 2026