Fp1000

FDA UDI

Class I (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name: FP1000 FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Device Name: FP 1000 Cell Preparation System FDA UDI
Model / Reference: 624922 FDA UDI
Description: FP 1000 Cell Preparation System FDA UDI

Identifiers

Catalog Number: 624922 FDA UDI
Primary DI / UDI-DI: 15099590564353 FDA UDI
FDA Product Code: JQW 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

Yes

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

Fp1000 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 40f9ed6d-a817-49f7-87c5-ad7427698acb 34 fields · synced Jun 8, 2026