| Primary Device ID | 00840861102297 |
| NIH Device Record Key | ff3b211c-78d5-4a9d-9be9-a12e260c157a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersiPD |
| Version Model Number | 130832 |
| Company DUNS | 076594100 |
| Company Name | Fresenius Usa, 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx | |
| Phone | 1-800-323-5188 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861102297 [Primary] |
| FKX | System, Peritoneal, Automatic Delivery |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-22 |
| Device Publish Date | 2023-02-14 |
| 00840861102297 | VersiPD Dialysate Solution Bag Case |
| 00840861102198 | VersiPD Cycler |
| 00840861102280 | VersiPD Cart |