AccessGUDID - DEVICE: Diatro•Hypoclean CC (05999883586631)

GUDID

Device Identifier (DI) Information

Brand Name: Diatro•Hypoclean CC
Version or Model: D801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D8011
Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Primary DI Number: 05999883586631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 427395277 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
JCB	Detergent

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 100 Milliliter

Device Record Status

Public Device Record Key: f57185b1-76cf-4d01-8c8f-0a55c5c3dd2a
Public Version Date: May 02, 2023
Public Version Number: 1
DI Record Publish Date: April 24, 2023