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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, clot activator FDA UDI
Device Name
VACUETTE® TUBE 9 ml Z Serum Clot Activator 16x100 red cap-black ring, special label, non-ridged FDA UDI
Model / Reference
455092CSS FDA UDI
Description
VACUETTE® TUBE 9 ml Z Serum Clot Activator 16x100 red cap-black ring, special label, non-ridged FDA UDI

Identifiers

Catalog Number
455092CSS FDA UDI
Primary DI / UDI-DI
29120017579599 FDA UDI
510(k) Number
K960858 FDA UDI
K983952 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, clot activator 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:

BK050028 also covers:

K960858 also covers:

K983952 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 4231b221-a2f1-4311-9474-95ca7aa56f2d 37 fields · synced May 31, 2026