| Primary Device ID | B321598223010 | 
| NIH Device Record Key | 5377476d-f2bd-4f9e-963f-d89816ac11ad | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Fetal Monitor Remote Display | 
| Version Model Number | t5545 | 
| Company DUNS | 113412019 | 
| Company Name | CLINICOMP INTERNATIONAL, 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 | false | 
| OTC Over-The-Counter | false | 
| Phone | 8003508202 | 
| radine.pobuda@clinicomp.com | |
| Phone | 8003508202 | 
| radine.pobuda@clinicomp.com | |
| Phone | 8003508202 | 
| radine.pobuda@clinicomp.com | |
| Phone | 8003508202 | 
| radine.pobuda@clinicomp.com | |
| Phone | 8003508202 | 
| radine.pobuda@clinicomp.com | 
| Weight | 3.5 Pound | 
| Depth | 9 Inch | 
| Height | 8 Inch | 
| Width | 2 Inch | 
| Weight | 3.5 Pound | 
| Depth | 9 Inch | 
| Height | 8 Inch | 
| Width | 2 Inch | 
| Weight | 3.5 Pound | 
| Depth | 9 Inch | 
| Height | 8 Inch | 
| Width | 2 Inch | 
| Weight | 3.5 Pound | 
| Depth | 9 Inch | 
| Height | 8 Inch | 
| Width | 2 Inch | 
| Weight | 3.5 Pound | 
| Depth | 9 Inch | 
| Height | 8 Inch | 
| Width | 2 Inch | 
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius | 
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius | 
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius | 
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius | 
| Handling Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B321598223010 [Primary] | 
| HGM | System, Monitoring, Perinatal | 
| 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 | 2016-09-22 | 
| B321600226100010 | 27 Wall Mount | 
| B321600226100 | 27 DeskTop | 
| B321600226000010 | 27 Wall Mount | 
| B321600226000 | 27 DeskTop | 
| B321600225000010 | 27 Wall Mount | 
| B321600225000 | 27 DeskTop | 
| B321598226000 | 4K 55 | 
| B321598225010 | 4K 55 | 
| B321598223020 | t5745 | 
| B321598223010 | t5545 | 
| B321598221010020 | ETCX X98-1 (CM9) | 
| B32160022611001 | 27" Wall Mount | 
| B32159822601 | NUC8i3BEK | 
| B32160022611 | 27" DeskTop | 
| B321598226010 | NUC8i3BEK | 
| B321600226110 | 27" DeskTop | 
| B321600226110010 | 27" Wall Mount | 
| B321340226010 | FMRD 4K 55" |