ABX MINIDIL LMG (10L)

GUDID 03610230004562

HORIBA ABX SAS

Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

Primary Device ID	03610230004562
NIH Device Record Key	8bb93354-ae0f-423f-bc37-dcdcee6439f5
Commercial Distribution Status	In Commercial Distribution
Brand Name	ABX MINIDIL LMG (10L)
Version Model Number	1210802010
Company DUNS	273647420
Company Name	HORIBA ABX SAS
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230004562 [Primary]

FDA Product Code

GIF	Diluent, Blood Cell

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2023-06-02
Device Publish Date	2016-08-16

Devices Manufactured by HORIBA ABX SAS

03610230005392 - ABX PENTRA HBA1C WB	2024-07-16
03610230005408 - ABX PENTRA HBA1C WB CAL	2024-07-16
03610230005415 - ABX PENTRA HBA1C WB CONTROL	2024-07-16
03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT	2024-07-16
03610230008157 - NUCEDIFF (1L)	2024-06-07
03610230008508 - Yumizen SPS	2024-06-07
03610230008928 - Yumizen T6000	2024-06-07 Right module SPS only
03610230008935 - Yumizen T6000	2024-06-07 Right module Inst only