AK 98 955607
GUDID 07332414124519
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.
GAMBRO AB
Haemodialysis system, institutional/home-use| Primary Device ID | 07332414124519 |
| NIH Device Record Key | fc37e6f8-721e-4b36-93f1-37ab7a4dde31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AK 98 |
| Version Model Number | 955607 |
| Catalog Number | 955607 |
| Company DUNS | 354021099 |
| Company Name | GAMBRO AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Width | 585 Millimeter |
| Depth | 620 Millimeter |
| Height | 1305 Millimeter |
| Width | 585 Millimeter |
| Depth | 620 Millimeter |
| Height | 1305 Millimeter |
| Width | 585 Millimeter |
| Depth | 620 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
| Depth | 620 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
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| Width | 585 Millimeter |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
| Special Storage Condition, Specify | Between 0 and 0 *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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414124519 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201809
FDA Product Code
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-30 |
| Device Publish Date | 2021-03-22 |
Devices Manufactured by GAMBRO AB
| 37332414127214 - CLCA - CLEANCART A | 2023-12-11 CleanCart A |
| 37332414127221 - CLCC - CLEANCART C | 2023-12-11 CleanCart C |
| 07332414124519 - AK 98 | 2021-03-30Intended 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. |
| 07332414124519 - AK 98 | 2021-03-30 Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body |
| 07332414126766 - PRISMAFLEX | 2019-03-11 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an |
| 37332414107728 - MARS TREATMENT KIT TYPE 1116/1 - X-MARS US | 2019-02-13 The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with |
| 37332414106950 - Mars Treatment Kit | 2018-07-06 The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing |
| 37332414088317 - BiCart | 2018-07-06 Sodium Bicarbonate for Hemodialysis |
| 07332414105266 - Prismaflex | 2018-07-06 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an |
Trademark Results [AK 98]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AK 98 87626795 5630574 Live/Registered |
Gambro Lundia AB 2017-09-28 |
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