| Primary Device ID | 06973166110033 |
| NIH Device Record Key | c800bf68-9462-4d19-8111-77d1becee8c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QudraView |
| Version Model Number | 100 |
| Company DUNS | 554511443 |
| Company Name | CompAI Healthcare (Shenzhen) 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 | true |
| 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 | +8651267236750 |
| support@comp-ai.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973166110033 [Primary] |
| GS1 | 16973166110030 [Package] Package: [10 Units] In Commercial Distribution |
| NNI | Container, Specimen, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-11 |
| Device Publish Date | 2021-05-03 |
| 06973166110057 - QuadraView | 2021-08-16 Specimen Container |
| 06973166110033 - QudraView | 2021-05-11Specimen Hold |
| 06973166110033 - QudraView | 2021-05-11 Specimen Hold |
| 06973166110026 - TrueView | 2021-02-01 Specimen Radiography System |