| Primary Device ID | 04931921902844 |
| NIH Device Record Key | 015b2ccc-6cc1-4f7c-acca-9b1403ad6233 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cap-ONE |
| Version Model Number | TG-980P |
| Catalog Number | TG-980P |
| Company DUNS | 690568050 |
| Company Name | NIHON KOHDEN CORPORATION |
| 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 | 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 |
| Phone | +1(800)325-0283 |
| info@nkusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04931921902844 [Primary] |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-19 |
| 04931921902844 | CO2 Sensor Kit, CapOne 2nd Gen |
| 04931921885635 | CO2 Sensor Kit, CapOne 2nd Gen |
| 04931921865767 | CO2 Sensor Kit for Sleep, CapOne |
| 04931921865750 | CO2 Sensor Kit, CapOne |
| 14931921904043 | Adult Cap-ONE Biteblock |
| 14931921902568 | cap-One mask, adult, large |
| 14931921902551 | cap-ONE mask, adult, large |
| 14931921902544 | cap-One mask, adult |
| 14931921902537 | cap-ONE mask, adult |
| 14931921900373 | EtCO2 Nasal / Oral Probe w/ pressure control, pediatric |
| 14931921900359 | EtCO2 Nasal / Oral Probe w/ pressure control, Adult |
| 14931921895709 | Cap-ONE Mask, Infant |
| 14931921886202 | Cap-ONE Mask, Pediatric |
| 14931921883744 | EtCO2 Nasal / Oral Probe, Pediatric |
| 14931921883713 | EtCO2 Nasal / Oral Probe, Adult |
| 14931921869038 | Nasal adapter for TG-920P (oxygen cannula adjustment) |
| 04931921025727 | CO2 Sensor Kit |
| 04931921010334 | cap-ONE Nasal Adapter, Pediatric, w/ Oxygen tube |
| 04931921010303 | cap-ONE Nasal Adapter, Pediatric |
| 04931921010273 | cap-ONE Nasal Adapter, Adult, w/ Oxygen tube |
| 04931921010235 | cap-ONE Nasal Adapter, Adult |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAP-ONE 76572306 3145915 Live/Registered |
NIHON KOHDEN CORPORATION 2004-01-28 |