| Primary Device ID | 10840861100771 |
| NIH Device Record Key | 6ad93d80-aa82-40a5-a65e-b1563b6e30a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | stay.safe® |
| Version Model Number | 050-95003 |
| Company DUNS | 958291411 |
| Company Name | Fresenius Medical Care Holdings, Inc. |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)323-5188 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861100774 [Primary] |
| GS1 | 10840861100771 [Package] Contains: 00840861100774 Package: [100 Units] In Commercial Distribution |
| KDJ | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2015-10-02 |
| 10840861100771 | stay.safe® to Luer-lock Adapter, 4 inch |
| 10840861100801 | stay.safe® Catheter Extension Set with Luer-Lock, 6 inch |
| 10840861100795 | stay.safe® Catheter Extension Set with Luer-Lock, 18 inch |
| 10840861100788 | stay.safe® Catheter Extension Set with Luer-Lock, 12 inch |
| 10840861100764 | stay.safe® Catheter Extension Set with Safe-Lock®, 12 inch |
| 10840861100696 | Multiple Tubing Segment (MTS) Set with stay.safe® PIN Connectors |
| 10840861100580 | stay.safe® Drain Set |