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enspire

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name
enspire FDA UDI
Generic Name
Liquid sterilant sterilizer FDA UDI
Device Name
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System, 230, 50Hz FDA UDI
Model / Reference
enspire 3000 FDA UDI
Description
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System, 230, 50Hz FDA UDI

Identifiers

Catalog Number
ENLCS300023050601 FDA UDI
Primary DI / UDI-DI
00724995228477 FDA UDI
510(k) Number
K230930 FDA UDI
K243433 FDA UDI
FDA Product Code
FEB FDA UDI
GMDN Term
Liquid sterilant sterilizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

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: Liquid sterilant sterilizer

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

Similar devices

Also classified as Liquid sterilant sterilizer.

Cleared under the same submission

K243433 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI 0b802470-4a4e-4192-a293-abbcaf2c5b08 36 fields · synced Jun 8, 2026