| Primary Device ID | 10817640020698 |
| NIH Device Record Key | 903a7ced-514e-4f76-b222-f9f7bd0fb0e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tru-Fix Catheter Fixation Kit |
| Version Model Number | TFK-16 |
| Catalog Number | TFK-16 |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817640020691 [Primary] |
| GS1 | 10817640020698 [Package] Contains: 00817640020691 Package: Dispenser [5 Units] In Commercial Distribution |
| GS1 | 20817640020695 [Package] Package: Shipper [5 Units] In Commercial Distribution |
| HIBCC | H862TFK160 [Previous] |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-20 |
| Device Publish Date | 2022-05-12 |
| H862TFK162 | Tru-Fix Catheter Fixation Kit - 16F |
| H862TFK142 | Tru-Fix Catheter Fixation Kit - 14F |
| H862TFK122 | Tru-Fix Catheter Fixation Kit - 12F |
| H862TFK102 | Tru-Fix Catheter Fixation Kit - 10F |
| H862TFK082 | Tru-Fix Catheter Fixation Kit - 8F |
| H862TFK062 | Tru-Fix Catheter Fixation Kit - 6F |
| H862TFDR2 | Tru-Fix Fixation Dressing Replacement |
| 10817640020698 | Tru-Fix Catheter Fixation Kit - 16F |
| 10817640020681 | Tru-Fix Catheter Fixation Kit - 14F |
| 10817640020674 | Tru-Fix Catheter Fixation Kit - 12F |
| 10817640020667 | Tru-Fix Catheter Fixation Kit - 10F |
| 10817640020650 | Tru-Fix Catheter Fixation Kit - 8F |
| 10817640020643 | Tru-Fix Catheter Fixation Kit - 6F |
| 10817640020636 | Tru-Fix Fixation Dressing Replacement |