AccessGUDID - DEVICE: Data Collection Mixer DCM3000 (BASIC) (08809241446446)

GUDID

Device Identifier (DI) Information

Brand Name: Data Collection Mixer DCM3000 (BASIC)
Version or Model: DCM3000B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM760
Company Name: CENTRON CORPORATION

Primary DI Number: 08809241446446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557821760 *Terms of Use

Device Description: The Data Collection Mixer DCM3000 is an electromechanical blood mixing and weighing device intended to maintain blood homogeneity during blood donation, and automatically clamps tubing when target volume is achieved equipped with convenient as barcode reading and remote control system. The mixer has two operation modes, DATA mode and BASIC mode and operates on dual power sources- AC power adaptor and the rechargeable battery pack.

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):	No
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
KSQ	Device, Blood Mixing And Blood Weighing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Length: 40.0 Centimeter
Width: 20.0 Centimeter
Height: 17.6 Centimeter
Weight: 3.4 Kilogram

Device Record Status

Public Device Record Key: f8ff7b06-a77d-4e4c-9935-653b313ad06e
Public Version Date: April 13, 2020
Public Version Number: 1
DI Record Publish Date: April 03, 2020