| Primary Device ID | 16975339621176 |
| NIH Device Record Key | 47fb2c82-f5c3-49e7-801a-c7b1a019a7c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BubbleView® |
| Version Model Number | C50-C |
| Company DUNS | 723490133 |
| Company Name | MacroLux Medical Technology Co., Ltd. |
| Device Count | 1 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975339621179 [Primary] |
| GS1 | 16975339621176 [Package] Contains: 06975339621179 Package: box [5 Units] In Commercial Distribution |
| GS1 | 26975339621173 [Package] Package: carton [2 Units] In Commercial Distribution |
| FAJ | Cystoscope And Accessories, Flexible/Rigid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
| 16975339621206 | BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR |
| 16975339621190 | BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CB |
| 16975339621183 | BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CR |
| 16975339621176 | BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C |
| 16975339621947 | C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145° |