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| 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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