HemoMix 4

GUDID 08033928530184

HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached

DELCON SRL

Blood donation rocker
Primary Device ID08033928530184
NIH Device Record Key5c0f7dc2-c8e8-42e9-ad20-06769e77916c
Commercial Distribution Discontinuation2030-04-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoMix 4
Version Model NumberHMIX4.02 standard version
Company DUNS440621212
Company NameDELCON SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS108033928530184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYJDevice, Mixing And Weighing, Semi-Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-20
Device Publish Date2020-03-12

On-Brand Devices [HemoMix 4]

08033928530184HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula
08033928530177HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula
08033928530597HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula
08033928530580HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.