DEVICE: PeraChek (00898021000242)

Device Identifier (DI) Information

PeraChek
1701-01
In Commercial Distribution
1701-01
Angelini Pharma Inc.
00898021000242
GS1

1
078843940 *Terms of Use
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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?
58107 Hydrogen peroxide device disinfectant/sterilant test strip
A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of hydrogen peroxide (H2O2) in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
LIF Dialyzer Reprocessing System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980164 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 60 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
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Clinically Relevant Size

[?]
Size Type Text
Width: 0.2 Inch
Length: 3.25 Inch
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Device Record Status

e5e52977-ef04-4b6d-a861-2d86b449ef23
February 15, 2023
4
May 23, 2017
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-726-2308
customerservice@angelini-us.com
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