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Vacuette

FDA UDI

Class II (US FDA UDI)

by Greiner Bio-One GmbH

Identity

Trade Name
Vacuette FDA UDI
Generic Name
Evacuated blood collection tube IVD, no additive FDA UDI
Device Name
VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-black ring, non-ridged, USA FDA UDI
Model / Reference
454318 FDA UDI
Description
VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-black ring, non-ridged, USA FDA UDI

Identifiers

Catalog Number
454318 FDA UDI
Primary DI / UDI-DI
29120017577052 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, no additive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 FDA UDI
Commercial Distribution
Not 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

Vacuette by Greiner Bio-One GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BK040066 also covers:

BK050026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greiner Bio-One GmbH

Sources (1)

  • FDA UDI bb6e5423-d8af-49f3-b2fa-6479488e0874 37 fields · synced May 31, 2026