| Primary Device ID | 26938634484164 |
| NIH Device Record Key | f4eee48b-0a8c-475f-ab4c-db39873d334d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Silicone Foley Catheter |
| Version Model Number | Two-way 10Fr |
| Catalog Number | FX-021031 |
| 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 | 06938634484160 [Primary] |
| GS1 | 16938634484167 [Package] Contains: 06938634484160 Package: [10 Units] In Commercial Distribution |
| GS1 | 26938634484164 [Package] Contains: 16938634484167 Package: [20 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 | 10 |
| Public Version Date | 2024-06-18 |
| Device Publish Date | 2016-09-20 |
| 26938634484225 | Two-way 22Fr |
| 26938634484157 | Two-way 8Fr |
| 26938634484140 | Two-way 6Fr |
| 26938634484164 | Two-way 10Fr |