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Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Non-evacuated blood collection tube IVD, no additive FDA UDI
Device Name
Blood Collection Tube,Silicone Coated Tube, Silicone Coated Red Stopper, No Additive, 15 mL Draw FDA UDI
Model / Reference
8881301819 FDA UDI
Description
Blood Collection Tube,Silicone Coated Tube, Silicone Coated Red Stopper, No Additive, 15 mL Draw FDA UDI

Identifiers

Catalog Number
8881301819 FDA UDI
Primary DI / UDI-DI
10884527002931 FDA UDI
FDA Product Code
GIM FDA UDI
GMDN Term
Non-evacuated blood collection tube IVD, no additive 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

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

Dimensions & Sizes

Size
Outer Diameter — 16 Millimeter FDA UDI
Length — 125 Millimeter FDA UDI
Total Volume — 15 Milliliter FDA UDI

Category: Non-evacuated blood collection tube IVD, no additive

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

Similar devices

Also classified as Non-evacuated blood collection tube IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 3e284af3-d7b5-4807-bad5-e6e26ae91122 37 fields · synced Jun 1, 2026