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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, K3EDTA/sodium fluoride FDA UDI
Device Name
VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, non-ridged FDA UDI
Model / Reference
454221 FDA UDI
Description
VACUETTE® TUBE 2 ml FE Sodium Fluoride / K3EDTA 13x75 grey cap-white ring, non-ridged FDA UDI

Identifiers

Catalog Number
454221 FDA UDI
Primary DI / UDI-DI
29120017570831 FDA UDI
510(k) Number
K971239 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, K3EDTA/sodium fluoride 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

Category: Evacuated blood collection tube IVD, K3EDTA/sodium fluoride

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

Similar devices

Also classified as Evacuated blood collection tube IVD, K3EDTA/sodium fluoride.

Cleared under the same submission

K971239 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 1111b136-9d72-4c3c-a468-42ffbe1532d1 36 fields · synced May 30, 2026