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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, anticoagulant FDA UDI
Device Name
VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, non-ridged, High Altitude FDA UDI
Model / Reference
454029H FDA UDI
Description
VACUETTE® TUBE 4 ml LH Lithium Heparin 13x75 green cap-black ring, non-ridged, High Altitude FDA UDI

Identifiers

Catalog Number
454029H FDA UDI
Primary DI / UDI-DI
29120017579841 FDA UDI
510(k) Number
K960857 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, anticoagulant 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

K960857 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 ad2142d2-0e6a-4781-8b94-b0e684aaaed5 37 fields · synced May 31, 2026