DEVICE: AK 98 (07332414124519)
Device Identifier (DI) Information
AK 98
955607
In Commercial Distribution
955607
GAMBRO AB
955607
In Commercial Distribution
955607
GAMBRO AB
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
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Width: 585 Millimeter |
Depth: 620 Millimeter |
Height: 1305 Millimeter |
Device Record Status
fc37e6f8-721e-4b36-93f1-37ab7a4dde31
December 07, 2023
6
March 22, 2021
December 07, 2023
6
March 22, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
medinfo_medproducts@baxter.com
medinfo_medproducts@baxter.com