| Primary Device ID | 26938634494835 |
| NIH Device Record Key | 5d189cc8-d0eb-4585-b42d-43bd6e43362d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Silicone Foley Catheter Two-way 18Fr |
| Version Model Number | 110-FX-021840 |
| Company DUNS | 547055364 |
| Company Name | Guangdong Baihe Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | 06938634494831 [Primary] |
| GS1 | 16938634494838 [Package] Contains: 06938634494831 Package: [10 Units] In Commercial Distribution |
| GS1 | 26938634494835 [Package] Contains: 16938634494838 Package: [200 Units] In Commercial Distribution |
| EZL | Catheter, Retention Type, Balloon |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-09-20 |
| 26938634494835 | 110-FX-021840 |
| 26938634494828 | 040-FX-021840 |