| Primary Device ID | 07640110981207 |
| NIH Device Record Key | 08c80674-b2c2-4193-aa9e-d07a8d0c424b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Low Profile Peripheral |
| Version Model Number | 616.360.7070-A |
| Company DUNS | 097736867 |
| Company Name | PFM MEDICAL INCORPORATED |
| 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 | 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 7607588749 |
| regulatory@pfmmedicalusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640110981207 [Package] Contains: 07640110987728 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 07640110987728 [Primary] |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-06 |
| Device Publish Date | 2020-02-27 |
| 76401109877426 | Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter |
| 76401109877280 | Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter |
| 76401109877044 | Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter |
| 07640110981771 | Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter |
| 07640110981207 | Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter |
| 07640110981764 | Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter |