| Primary Device ID | 10813623017020 |
| NIH Device Record Key | 7c975506-123f-4075-8125-57fc15f39671 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASEPT |
| Version Model Number | M7002 |
| Catalog Number | M7002 |
| 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 | true |
| 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 |
| Phone | 7607588749 |
| customerservice@pfmmedicalusa.com | |
| Phone | 7607588749 |
| customerservice@pfmmedicalusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813623017023 [Primary] |
| GS1 | 10813623017020 [Package] Contains: 00813623017023 Package: [10 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-05 |
| 10813623017020 | ASEPT 600mL Drainage Kit |
| 10813623016986 | ASEPT 1,000mL Starter Kit |
| 10813623016979 | ASEPT 600mL Starter Kit |
| 10813623015743 | ASEPT 600mL Drainage Bottle with Y-Site Drain |
| 00813623012066 | ASEPT 1000mL Drainage Bottle with Y-Site Drain |
| 20813623011384 | ASEPT Procedure Pack |
| 20813623017058 | ASEPT Drainage Line Set |
| 20813623017041 | ASEPT Replacement Valve |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ASEPT 88598012 not registered Live/Pending |
PFM MEDICAL, INC. 2019-08-29 |
![]() ASEPT 85138106 4015067 Live/Registered |
PFM Medical, Inc. 2010-09-24 |
![]() ASEPT 76186686 3310210 Live/Registered |
ASEPT INTERNATIONAL AB 2000-12-22 |