Yumizen P8000

GUDID 03610230008966

1 connexion

HORIBA ABX SAS

Clinical laboratory information system
Primary Device ID03610230008966
NIH Device Record Key8ce7f34c-03af-4023-90a2-df1b0986ac52
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen P8000
Version Model Number1300033327
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230008966 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-15
Device Publish Date2025-07-07

Devices Manufactured by HORIBA ABX SAS

03610230008966 - Yumizen P80002025-07-151 connexion
03610230008966 - Yumizen P80002025-07-15 1 connexion
03610230009444 - Yumizen H25002024-12-09
03610230009451 - Yumizen H25002024-12-09
03610230009611 - ABX Minocal2024-10-07
03610230008584 - BFTROL2024-10-04 BF Hematology control
03610230009581 - ABX Minotrol 162024-10-03
03610230009598 - ABX Minotrol 162024-10-03
03610230009604 - ABX Minotrol 162024-10-03

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