AccessGUDID - DEVICE: HemoMix 3 (08033928530016)

GUDID

Device Identifier (DI) Information

Brand Name: HemoMix 3
Version or Model: HMIX3.485
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DELCON SRL

Primary DI Number: 08033928530016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 440621212 *Terms of Use

Device Description: HemoMix 3 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 (Basic version))

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):	Yes
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?
36405	Blood donation rocker	A mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes which lie in a cradle-like holder attached to this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYJ	Device, Mixing And Weighing, Semi-Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK180229	0

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7010046-f270-434e-b4f1-7140929edf1e
Public Version Date: November 04, 2024
Public Version Number: 2
DI Record Publish Date: December 07, 2022