| Primary Device ID | 10191237000011 |
| NIH Device Record Key | 3be4ad50-16ea-48c1-a9da-e9d0fb126b11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SA-3000P |
| Version Model Number | SA-3000P |
| Catalog Number | SA-3000P |
| Company DUNS | 688247753 |
| Company Name | Medicore Co., Ltd. |
| 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 | 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 | +82220562650 |
| bkyoo@medi-core.com |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191237000014 [Primary] |
| GS1 | 10191237000011 [Package] Contains: 00191237000014 Package: Carton [1 Units] In Commercial Distribution |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-18 |
| Device Publish Date | 2019-04-10 |
| 00191237000069 - IRIS-XP | 2021-11-09 |
| 10191237000011 - SA-3000P | 2019-04-18 |
| 10191237000011 - SA-3000P | 2019-04-18 |
| 40191237000036 - Max Pulse | 2019-03-13 |