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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, sodium citrate FDA UDI
Device Name
VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black ring, sandwich tube, non-ridged, High Altitude, USA FDA UDI
Model / Reference
454331 FDA UDI
Description
VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black ring, sandwich tube, non-ridged, High Altitude, USA FDA UDI

Identifiers

Catalog Number
454331 FDA UDI
Primary DI / UDI-DI
29120017577007 FDA UDI
510(k) Number
K971221 FDA UDI
FDA Product Code
GIM FDA UDI
GMDN Term
Evacuated blood collection tube IVD, sodium citrate 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, sodium citrate

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, sodium citrate.

Cleared under the same submission

K971221 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 8eb05f14-943e-4fb5-8d48-69ffb5fda2b0 36 fields · synced Jun 1, 2026