| Primary Device ID | 10841522123634 |
| NIH Device Record Key | 39bd1f04-ae6e-421e-bc27-91e3de034281 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intesys® Clinical Suite |
| Version Model Number | Smart Disclosure |
| Catalog Number | 92842 |
| Company DUNS | 145581588 |
| Company Name | SPACELABS HEALTHCARE (WASHINGTON), INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522123634 [Primary] |
| OUG | Medical device data system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-08-18 |
| Device Publish Date | 2018-08-08 |
| 10841522123641 | HL7 VITAL SIGNS INTERFACE,92843 |
| 10841522123634 | HL7,ADT INTERFACE,92842 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INTESYS 77464782 3549710 Live/Registered |
SPACELABS HOLDINGS, INC. 2008-05-02 |
![]() INTESYS 74695568 2067753 Dead/Cancelled |
SPACELABS MEDICAL, INC. 1995-06-30 |