Celerity

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name: Celerity FDA UDI
Generic Name: Biological sterilization indicator FDA UDI
Device Name: The Celerity 20 HP Biological Indicator is used with the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers. FDA UDI
Model / Reference: LCB044 FDA UDI
Description: The Celerity 20 HP Biological Indicator is used with the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers. FDA UDI

Identifiers

Catalog Number: LCB044 FDA UDI
Primary DI / UDI-DI: 10724995154230 FDA UDI
510(k) Number: K171504 FDA UDI
K172474 FDA UDI
K172752 FDA UDI
K181429 FDA UDI
K183294 FDA UDI
K231490 FDA UDI
FDA Product Code: FRC FDA UDI
GMDN Term: Biological sterilization indicator 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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: Biological sterilization indicator

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

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Also classified as Biological sterilization indicator.

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Bionova® — TERRAGENE S.A. · Class II
Bionova® — TERRAGENE S.A. · Class II
Dual Spore Strips - Test — MESA LABORATORIES, INC. · Class II

Cleared under the same submission

K183294 also covers:

Celerity — STERIS CORPORATION

K231490 also covers:

VERIFY — STERIS CORPORATION

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: Steris Corporation

Sources (1)

FDA UDI 02162c79-4118-4b15-b528-ae5a4fc82e61 37 fields · synced Jun 6, 2026