DEVICE: Celerity (00724995215941)

Device Identifier (DI) Information

Celerity
LCB060
In Commercial Distribution
LCB060
STERIS CORPORATION
00724995215941
GS1

1
868205779 *Terms of Use
The Celerity Incubator is used to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55-60 Degrees Celsius for a fluorescent result.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46944 Test tube heater
An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRC Indicator, biological sterilization process
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K213881 000
K223715 000
K250061 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a97a7677-ef26-4f9f-8e77-dd6a48826657
April 08, 2025
3
September 23, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)548-4873
xx@xx.xx
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