Primary Device ID | 10846446024913 |
NIH Device Record Key | e04969ec-f499-45c7-9189-2277437538d2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Somnostar |
Version Model Number | 16623 |
Catalog Number | 16623 |
Company DUNS | 830432451 |
Company Name | Carefusion Corporation |
Device Count | 1 |
DM Exempt | true |
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 | false |
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 | 10846446024913 [Primary] |
OLV | Standard Polysomnograph With Electroencephalograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-07-22 |
Device Publish Date | 2016-09-13 |
10846446033298 | SOMNOSTAR 11 UPGRADE |
10846446066050 | SWR KIT, SOMNOSTAR 11.2 HOTFIX |
10846446065046 | CD,SOMNOSTAR VER 11.1 |
10846446033328 | CD, LabManager HL7 Hotfix |
10846446033274 | SWR KIT SOMNOSTAR VER 11 SWR BUNDLE FIRST LIC |
10846446033267 | SOMNOSTAR SECURITY ADMIN |
10846446033250 | SWR,KIT SOMNOSTAR 10.2 VID UPG |
10846446032628 | SWR KIT RPT CENTER SSPRO VER 11 |
10846446032611 | SWR KIT SSPRO NEW SYS VER 11 |
10846446032550 | SWR KIT SSPRO SOFTWARE VER 11 |
10846446032260 | SOFTWARE KIT LABMANAGER SQL PATCH |
10846446032208 | LABMANAGER WORD 2013 REPORT HOTFIX CD |
10846446032185 | SWR KIT SSPRO NEW SYS VER 10 |
10846446031485 | SWR KIT SSPRO SOFTWARE VER 10.2 |
10846446025415 | SWR KIT RPT CENTER SSPRO VER 10 |
10846446021080 | SWR KIT LABMGR SQL SETUP WIZARD |
10846446020274 | SWR KIT SSPRO SOFTWARE VER 9 |
10846446024913 | PWR SPLY/+15V 50W PSU V32 |
10846446020151 | CABLE ASSY,OVERMOLD,50 PIN,HEADBOX |
10846446020144 | ASSY/AMP SLEEP RC 9.1+ |
10846446020076 | HEADBOX ASSEMBLY |
10846446033243 | SOMNOSTAR 10.2 VIDEO UPGRADE KIT |
10846446032604 | SOMNOSTAR Z4 SYSTEM VER 11 |
10846446032598 | ACQ STN 1 BED Z4 VER 11 |
10846446025422 | SOMNOSTAR Z4 SYSTEM VER 10 |
10846446025392 | ACQ STN 1 BED Z4 VER 10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SOMNOSTAR 75126859 2117557 Live/Registered |
SENSORMEDICS CORPORATION 1996-06-28 |