DEVICE: PeraChek (00898021000242)
Device Identifier (DI) Information
PeraChek
1701-01
In Commercial Distribution
1701-01
Angelini Pharma Inc.
1701-01
In Commercial Distribution
1701-01
Angelini Pharma Inc.
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.
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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
LIF | Dialyzer Reprocessing System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K980164 | 000 |
Sterilization
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. |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 0.2 Inch |
Length: 3.25 Inch |
Device Record Status
e5e52977-ef04-4b6d-a861-2d86b449ef23
February 15, 2023
4
May 23, 2017
February 15, 2023
4
May 23, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-726-2308
customerservice@angelini-us.com
customerservice@angelini-us.com