| Primary Device ID | 10813623019109 |
| NIH Device Record Key | a5d7e151-c8b5-4aef-a7cf-e6f27b027280 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASEPT Peritoneal Drainage System |
| Version Model Number | M7058 |
| Catalog Number | M7058 |
| Company DUNS | 097736867 |
| Company Name | PFM MEDICAL INCORPORATED |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com | |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813623019102 [Primary] |
| GS1 | 10813623019109 [Package] Contains: 00813623019102 Package: [10 Units] In Commercial Distribution |
| FJS | Catheter, Peritoneal, Long-Term Indwelling |
| FMH | Container, Specimen, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-06 |
| Device Publish Date | 2015-10-15 |
| 10813623019109 | ASEPT 2,000mL Drainage Bag |
| 10813623017068 | ASEPT Peritoneal Drainage System |
| 10813623015378 | ASEPT 1,000mL Drainage Kit |
| 10813623014227 | ASEPT Drainage Bag with Procedure Pack |
| 10813623011158 | ASEPT Peritoneal Drainage System |
| 10813623011141 | ASEPT 1,000mL Drainage Kit |
| 20813623011117 | ASEPT Vented Lock Cap |