| Primary Device ID | 06944904086484 |
| NIH Device Record Key | 59c0d312-e787-426a-994b-a2d6f2a3bd07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable pouch(25/box) |
| Version Model Number | 115-032957-00 |
| Company DUNS | 654671304 |
| Company Name | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | +8675581888998 |
| service@mindray.com.cn |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944904086484 [Primary] |
| GS1 | 06944904090764 [Unit of Use] |
| MSX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2016-09-23 |
| 06944904031408 - BC-6D Hematology Control | 2023-10-27 |
| 06944904031422 - BC-RET Hematology Control | 2023-10-27 |
| 06903053039673 - L9-3s Transducer(FDA-SJM) | 2023-05-30 |
| 06903053039680 - P8-2Ts Transducer(FDA-SJM) | 2023-05-30 |
| 06903053039697 - SP5-1s Transducer(FDA-SJM) | 2023-05-30 |
| 06903053039703 - P8-2s Transducer(FDA-SJM) | 2023-05-30 |
| 06903053039710 - CW2s Transducer(FDA-SJM) | 2023-05-30 |
| 06903053039727 - L16-4Hs Transducer(FDA-SJM) | 2023-05-30 |