| Primary Device ID | 07640110982181 |
| NIH Device Record Key | de8db8b2-12b1-4a78-8b46-1af451bf3201 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tita Jet Light II |
| Version Model Number | 616.368.2087-HA |
| 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 | 07640110982181 [Package] Contains: 07640110988954 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 07640110988954 [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 |
| 76401109889542 | Tita Jet Light II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plug |
| 76401109889306 | Tita Jet Light II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Pl |
| 76401109879888 | Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter |
| 07640110982181 | Tita Jet Light II HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plug |
| 07640110982198 | Tita Jet Light II HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter and Silicone Pl |
| 07640110981757 | Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter |