| Primary Device ID | 08964004471049 |
| NIH Device Record Key | 33a1e1f8-369c-476a-845f-4a33865d31cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automated PD Set DS-1.B |
| Version Model Number | 1F1501 |
| Catalog Number | 1F1501 |
| Company DUNS | 645843231 |
| Company Name | BYONYKS PRIVATE LIMITED |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08964004471032 [Primary] |
| GS1 | 08964004471049 [Package] Contains: 08964004471032 Package: Box [7 Units] In Commercial Distribution |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-21 |
| Device Publish Date | 2025-11-13 |
| 08964004471049 - Automated PD Set DS-1.B | 2025-11-21This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler. |
| 08964004471049 - Automated PD Set DS-1.B | 2025-11-21 This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler. |
| 08964004471001 - X-1 APD Cycler | 2025-09-16 The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis. |
| 08964004471025 - Automated PD Set DS-1 | 2025-09-16 This Byonyks Automated PD Set DS-1 is compatible with the Byonyks X-1 APD Cycler. |