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Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Test tube/reservoir cap FDA UDI
Device Name
Sample Cup for 16 mm Tubes FDA UDI
Model / Reference
1270016000 FDA UDI
Description
Sample Cup for 16 mm Tubes FDA UDI

Identifiers

Catalog Number
1270016000 FDA UDI
Primary DI / UDI-DI
20884527002846 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Test tube/reservoir cap FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 2 Milliliter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI

Category: Test tube/reservoir cap

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

Similar devices

Also classified as Test tube/reservoir cap.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 44bdd99c-a517-49a2-bcc7-ceda25d5dee8 37 fields · synced Jun 8, 2026