AccessGUDID - DEVICE: 9MPSBRWIFI-MacoPress Smart and DMS WiFi Module-no breaker (03567051503197)

GUDID

Device Identifier (DI) Information

Brand Name: 9MPSBRWIFI-MacoPress Smart and DMS WiFi Module-no breaker
Version or Model: 9MPSBRWIFI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9MPSBRWIFI
Company Name: MACO PHARMA

Primary DI Number: 03567051503197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 577149081 *Terms of Use

Device Description: The MacoPress Smart (MPS) and DMS consist of two parts: the MacoPress Smart device and the DMS Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.

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?
61618	Blood component separator, automated	A mains electricity (AC-powered) device designed for the automated separation of whole blood or previously centrifuged blood into components [e.g., red blood cells (RBCs), platelets, leukocytes] for further processing or storage. It is a programmable device with a user interface that uses a mechanical separation method (e.g., pressure plates, microfluidics) to transfer the blood component(s) from the donor bag into a removable disposable receptacle. It may have additional features such as sensors, scales, and an automatic mechanism for opening the valve(s) on the donor bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSS	Supplies, Blood-Bank

FDA Premarket Submission

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

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: 9cdcf7a4-069a-4801-b94c-7dd0e179af52
Public Version Date: March 13, 2025
Public Version Number: 4
DI Record Publish Date: June 19, 2018