DEVICE: Diatro•Hypoclean CC (05999883586631)

Device Identifier (DI) Information

Diatro•Hypoclean CC
D801
In Commercial Distribution
D8011
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
05999883586631
GS1

1
427395277 *Terms of Use
Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on all hematology analyzers.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
59058 Wash/cleaning solution IVD, automated/semi-automated system
A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JCB Detergent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 32 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 100 Milliliter
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Device Record Status

f57185b1-76cf-4d01-8c8f-0a55c5c3dd2a
May 02, 2023
1
April 24, 2023
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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
15999883586638 10 05999883586631 In Commercial Distribution Cardboard
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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: 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

[?]
+3612794400
support@diatron.com
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