DEVICE: EZ-Chek (00858293006106)

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Device Record History
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Device Identifier (DI) Information
EZ-Chek
K100-0111
In Commercial Distribution
K100-0111
REPROCESSING PRODUCTS CORPORATION
00858293006106
GS1

1
796083392 *Terms of Use
Ozone (in Water) Test Strips
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
62444 Haemodialysis equipment residual chlorine test strip
A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change and visual comparison to a colour chart, the concentration of residual chlorine in water samples. It is typically used as a means to test whether chlorine has been adequately rinsed from haemodialysis equipment following disinfection. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K132344 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
f8773fd8-847b-4439-92ad-de92644533bf
August 16, 2019
4
January 19, 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
10858293006103 1 00858293006106 In Commercial Distribution bag
20858293006100 1 10858293006103 In Commercial Distribution box
30858293006107 22 20858293006100 In Commercial Distribution carton
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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

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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

[?]
No Customer Contact currently defined
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