AccessGUDID - DEVICE: AK 98 (07332414124519)

GUDID

Device Identifier (DI) Information

Brand Name: AK 98
Version or Model: 955607
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 955607
Company Name: GAMBRO AB

Primary DI Number: 07332414124519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354021099 *Terms of Use

Device Description: Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use.

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?
58131	Haemodialysis system, institutional/home-use	An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system 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 [?]
K201809	000
K232467	000

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: Transport and Storage Conditions: 10-93 RH non condensing, -20 to 70 deg C. Run a Disinfection program every day. After prolonged storage, change ultrafilter and run disinfection program

Clinically Relevant Size

[?]

Size Type Text
Width: 585 Millimeter
Depth: 620 Millimeter
Height: 1305 Millimeter

Device Record Status

Public Device Record Key: fc37e6f8-721e-4b36-93f1-37ab7a4dde31
Public Version Date: December 07, 2023
Public Version Number: 6
DI Record Publish Date: March 22, 2021