Vacuette

FDA UDI

Class II (US FDA UDI)

by Greiner Bio-One GmbH

Identity

Trade Name: Vacuette FDA UDI
Generic Name: Basic intravenous administration set, invasive FDA UDI
Device Name: SAFETY Blood Collection Set + Luer Adapter 23G x 3/4" tubing length 4" (10 cm), single-packed, sterile, not made with natural rubber latex FDA UDI
Model / Reference: 450084V1 FDA UDI
Description: SAFETY Blood Collection Set + Luer Adapter 23G x 3/4" tubing length 4" (10 cm), single-packed, sterile, not made with natural rubber latex FDA UDI

Identifiers

Catalog Number: 450084V1 FDA UDI
Primary DI / UDI-DI: 19120049208743 FDA UDI
510(k) Number: K011786 FDA UDI
K080235 FDA UDI
K121908 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Basic intravenous administration set, invasive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Basic intravenous administration set, invasive

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

Similar devices

Also classified as Basic intravenous administration set, invasive.

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SURFLO™ — Terumo Europe NV · Class II
ULTRAFLO-R — Innovative Medical Technologies, Inc. · Class II
SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II

Cleared under the same submission

K011786 also covers:

K080235 also covers:

K121908 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Greiner Bio-One GmbH

Sources (1)

FDA UDI c9a6ffa7-d4c6-43f6-b9e6-0da53868d6a0 36 fields · synced May 30, 2026