AccessGUDID - DEVICE: Prismaflex (07332414105266)

GUDID

Device Identifier (DI) Information

Brand Name: Prismaflex
Version or Model: 5.XX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 113081
Company Name: GAMBRO AB

Primary DI Number: 07332414105266
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 354021099 *Terms of Use

Device Description: The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.

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?
58130	Haemodialysis system, institutional	An assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, high permeability with or without sealed dialysate system

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
Special Storage Condition, Specify: Non-condensing humidity
Special Storage Condition, Specify: Keep dry, Fragile handle with care, Do not stack
Storage Environment Temperature: between 0 and 130 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -18 and 54 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 38 Degrees Celsius
Handling Environment Temperature: between 60 and 100 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cfa9ab3-04e5-4056-907f-8020482f1817
Public Version Date: December 18, 2023
Public Version Number: 5
DI Record Publish Date: October 17, 2015