AccessGUDID - DEVICE: B.BRAUN (04046964337017)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 706210A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 706210A
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964337017
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: The Plasmat® Futura System

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?
16405	Apheresis system	An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL

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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0d27921-3b92-48c2-9d7b-6670fa88d503
Public Version Date: November 23, 2023
Public Version Number: 7
DI Record Publish Date: September 15, 2014