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Vacuette

FDA UDI

Class I (US FDA UDI)

by Greiner Bio-One GmbH

Identity

Trade Name
VACUETTE FDA UDI
Generic Name
General specimen container IVD, no additive, sterile FDA UDI
Device Name
Urine CCM Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed FDA UDI
Model / Reference
453043 FDA UDI
Description
Urine CCM Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed FDA UDI

Identifiers

Primary DI / UDI-DI
19120049209092 FDA UDI
FDA Product Code
JSM FDA UDI
GMDN Term
General specimen container IVD, no additive, sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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: General specimen container IVD, no additive, sterileEvacuated blood collection tube IVD, K3EDTA

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

Similar devices

Also classified as Evacuated blood collection tube IVD, K3EDTA.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 216d3fc6-419e-4204-9644-3e459fcc004a 33 fields · synced Jun 6, 2026