DEVICE: Celerity (10724995218581)

Device Identifier (DI) Information

Celerity
PCC079
In Commercial Distribution
PCC079
ALBERT BROWNE LIMITED
10724995218581
GS1

200
218172765 *Terms of Use
Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
35362 Chemical/physical sterilization process indicator
A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QKM A chemical vapor sterilization multivariable chemical indicator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K213262 000
K231488 000
No CLOSE

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

03f6286a-95e8-4b41-be4a-a36c292786db
February 21, 2025
5
August 10, 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
50724995218589 40 10724995218581 In Commercial Distribution Case
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Secondary DI

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

[?]
Unit of Use DI Number: 00724995218584 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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