SAMPLE CUP - BLUE

GUDID 03610230006702

HORIBA ABX SAS

General specimen container IVD, no additive, non-sterile
Primary Device ID03610230006702
NIH Device Record Keyf599348f-3dd5-4c08-95e1-dcc56c665023
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAMPLE CUP - BLUE
Version Model Number1220001765
Company DUNS273647420
Company NameHORIBA ABX SAS
Device Count1000
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103610230006702 [Primary]
GS103610230008133 [Unit of Use]

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-01-22
Device Publish Date2016-09-20

Devices Manufactured by HORIBA ABX SAS

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
03610230005545 - ABX PENTRA CK CONTROL2024-07-18

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