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Celerity

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name
Celerity FDA UDI
Generic Name
Biological sterilization indicator reader FDA UDI
Device Name
The Celerity STEAM Incubator is designed to incubate and automatically read the Celerity 20 STEAM Biological Indicator (BI) for a fluorescent result within 20 minutes. FDA UDI
Model / Reference
Incubator FDA UDI
Description
The Celerity STEAM Incubator is designed to incubate and automatically read the Celerity 20 STEAM Biological Indicator (BI) for a fluorescent result within 20 minutes. FDA UDI

Identifiers

Catalog Number
LCB051 FDA UDI
Primary DI / UDI-DI
00724995201852 FDA UDI
510(k) Number
K173670 FDA UDI
FDA Product Code
FRC FDA UDI
GMDN Term
Biological sterilization indicator reader FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Biological sterilization indicator reader

Celerity by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biological sterilization indicator reader.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI 3e2e9ed3-3035-420a-960d-1fc68cac5159 36 fields · synced Jun 6, 2026