DEVICE: AK 98 (07332414124519)

Device Identifier (DI) Information

AK 98
955607
In Commercial Distribution
955607
GAMBRO AB
07332414124519
GS1

1
354021099 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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.
Active false
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FDA Product Code

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Product Code Product Code Name
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K201809 000
K232467 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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Size Type Text
Width: 585 Millimeter
Depth: 620 Millimeter
Height: 1305 Millimeter
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Device Record Status

fc37e6f8-721e-4b36-93f1-37ab7a4dde31
December 07, 2023
6
March 22, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+1(800)933-0303
medinfo_medproducts@baxter.com
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