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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 FDA UDI
Device Name
VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged FDA UDI
Model / Reference
454217 FDA UDI
Description
VACUETTE® TUBE 3 ml K3E K3EDTA 13x75 lavender cap-black ring, non-ridged FDA UDI

Identifiers

Catalog Number
454217 FDA UDI
Primary DI / UDI-DI
29120017571487 FDA UDI
510(k) Number
K042927 FDA UDI
K960860 FDA UDI
FDA Product Code
PJE FDA UDI
GMDN Term
Evacuated blood collection tube IVD, K3EDTA 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

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.

Cleared under the same submission

BK030001 also covers:

BK040018 also covers:

K042927 also covers:

K960860 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 b59147b2-c6e7-4c43-93d6-8b2493325e73 36 fields · synced Jun 6, 2026