| Primary Device ID | 06976041612035 |
| NIH Device Record Key | 74103278-2de2-4d04-940d-2de6b0d38b27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LEWIN |
| Version Model Number | CreBle 3000 |
| Company DUNS | 546175601 |
| Company Name | Shandong Lewin Medical Equipment Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06976041612035 [Primary] |
| GDC | Table, Operating-Room, Electrical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-17 |
| Device Publish Date | 2023-02-09 |
| 06976041611069 | CreLed 3300 |
| 06976041613049 | CreLife 6000 |
| 06976041613032 | CreLife 3000 |
| 06976041613025 | CreLife 2000 |
| 06976041613018 | CreLife 100 |
| 06976041612066 | CreBle 2100 |
| 06976041612059 | CreBle 1500 |
| 06976041612042 | CreBle 200 |
| 06976041612035 | CreBle 3000 |
| 06976041612028 | CreBle 2000 |
| 06976041612011 | CreBle 1000 |
| 06976041611144 | CreLed 150M |
| 06976041611137 | CreLed 310M |
| 06976041611120 | Hollow CreLed 5500M |
| 06976041611113 | CreLed 3300M |
| 06976041611106 | CreLed 5500M |
| 06976041611090 | Hollow CreLed 5500 |
| 06976041611083 | Hollow CreLed 5700 |
| 06976041611076 | Hollow CreLed 5700/5500 |
| 06976041611052 | CreLed 3400 |
| 06976041611045 | CreLed 3400/3300 |
| 06976041611038 | CreLed 5500 |
| 06976041611021 | CreLed 5700 |
| 06976041611014 | CreLed 5700/5500 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LEWIN 85911099 4450743 Live/Registered |
OptumInsight, Inc. 2013-04-22 |