| Primary Device ID | 16975339621954 |
| NIH Device Record Key | fcfcf777-ab16-4853-850a-d89e5ba6ced8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BubbleView |
| Version Model Number | C50-CR |
| 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 | 06975339621957 [Primary] |
| GS1 | 16975339621954 [Package] Contains: 06975339621957 Package: [5 Units] In Commercial Distribution |
| GS1 | 26975339621951 [Package] Package: [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 | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
| 16975339621947 - BubbleView® | 2025-09-15 C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145° |
| 16975339621954 - BubbleView | 2025-09-15C50-CR Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Reverse,U235°/D145° |
| 16975339621954 - BubbleView | 2025-09-15 C50-CR Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Reverse,U235°/D145° |
| 16975339628120 - CoralWell | 2025-09-03 |
| 16975339628137 - CoralWell | 2025-09-03 |
| 16975339628144 - CoralWell | 2025-09-03 |
| 16975339628151 - CoralWell | 2025-09-03 |
| 16975339628168 - CoralWell | 2025-09-03 |
| 16975339628175 - CoralWell | 2025-09-03 |