| Primary Device ID | 04987035388517 |
| NIH Device Record Key | 65282e18-d712-4813-9d8c-c80d5224c5aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POC-AS10 Auto sampler |
| Version Model Number | POC-AS10 |
| Company DUNS | 695318717 |
| Company Name | OTSUKA ELECTRONICS CO.,LTD. |
| 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 | false |
| Manufacturing Date | false |
| 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 | 1-888-637-3835 |
| xx@xx.xx |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987035388517 [Primary] |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-07 |
| Device Publish Date | 2019-10-30 |
| 04987035343417 - POCone Infrared Spectrophotometer | 2019-11-07 The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO |
| 04987035388517 - POC-AS10 Auto sampler | 2019-11-07The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. |
| 04987035388517 - POC-AS10 Auto sampler | 2019-11-07 The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared S |