| Primary Device ID | 06948909401280 |
| NIH Device Record Key | 68185476-3f0d-435c-9090-3ad7b5cf721a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bynex |
| Version Model Number | 3005 |
| Company DUNS | 420764429 |
| Company Name | Shaoxing Haoshide Medical Products 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 | 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 | 06948909401280 [Primary] |
| GS1 | 06948909453692 [Package] Package: case [30 Units] In Commercial Distribution |
| EXE | Protector, Ostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-11 |
| Device Publish Date | 2024-03-01 |
| 06948909401327 | Two-piece ostomy bag Convex Wafer |
| 06948909401310 | Two-piece ostomy bag Flat Wafer |
| 06948909401297 | One-piece Ostomy bag Flat |
| 06948909401389 | One-piece Ostomy bag Flat |
| 06948909401372 | Two-piece ostomy open bag |
| 06948909401365 | Two-piece ostomy bag Convex Wafer |
| 06948909401358 | Two-piece ostomy bag Flat Wafer |
| 06948909401341 | Two-piece ostomy Closed bag |
| 06948909401334 | Two-piece ostomy open bag |
| 06948909401303 | One-piece Ostomy bag Convex |
| 06948909401280 | Ostomy Care Accessories 10 pieces/box 30 boxes/carton |