EXALIS 113297
GUDID 07332414106126
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes i
GAMBRO DASCO SPA
Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system| Primary Device ID | 07332414106126 |
| NIH Device Record Key | 87defaf8-654e-4f4e-b470-eb469c854b60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXALIS |
| Version Model Number | 113297 |
| Catalog Number | 113297 |
| Company DUNS | 428788780 |
| Company Name | GAMBRO DASCO SPA |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414106126 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083158
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 | 2018-12-17 |
| Device Publish Date | 2018-11-16 |
On-Brand Devices [EXALIS]
| 07332414106126 | Exalis is an integrated product able to acquire, process and supply data required when running a |
| 07332414106119 | Exalis is an integrated product able to acquire, process and supply data required when running a |
Trademark Results [EXALIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXALIS 76317630 2674356 Live/Registered |
GAMBRO LUNDIA AB 2001-09-26 |
 EXALIS 76317629 2692388 Live/Registered |
GAMBRO LUNDIA AB 2001-09-26 |
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