PrepPlus 2

FDA UDI

Class I (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name: PrepPlus 2 FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Device Name: COULTER PrepPlus 2 FDA UDI
Model / Reference: 378600 FDA UDI
Description: COULTER PrepPlus 2 FDA UDI

Identifiers

Catalog Number: 378600 FDA UDI
Primary DI / UDI-DI: 15099590638191 FDA UDI
510(k) Number: K130253 FDA UDI
FDA Product Code: PER FDA UDI
GMDN Term: Specimen processing instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Specimen processing instrument IVD

PrepPlus 2 by Beckman Coulter, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Beckman Coulter, Inc.

Sources (1)

FDA UDI 8dbce4ae-c24d-41eb-9693-2d60563ca6e8 35 fields · synced Jun 6, 2026