| Primary Device ID | 00814905020137 |
| NIH Device Record Key | b959a4cd-c91c-48fb-8fb1-7042ef2b44d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Codonics SLS500i Operating Software |
| Version Model Number | 2.2.0 |
| Company DUNS | 101533727 |
| Company Name | CODONICS INC. |
| 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 | true |
| 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 |
| Phone | 4402431334 |
| support@codonics.com | |
| Phone | 4402431334 |
| support@codonics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814905020137 [Primary] |
| BSZ | Gas-Machine, Anesthesia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-23 |
| 00814905020137 | V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station |
| 00814905020021 | V2.1.3 Operating Software for the Codonics Safe Label System® 500i Point of Care Station |
| 00814905020014 | V2.1.2 Operating Software for the Codonics Safe Label System® 500i Point of Care Station |
| 00814905020007 | V2.1.1 Operating Software for the Codonics Safe Label System® 500i Point of Care Station |