| Primary Device ID | B16556410327073125152 |
| NIH Device Record Key | fd9cdead-6403-4fdd-be7b-dd80737e3636 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Leader Catheter with Button |
| Version Model Number | 5641 |
| Company DUNS | 967592978 |
| Company Name | Liberty Medical , Inc. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B16556410327073125152 [Primary] |
| IWJ | System, Applicator, Radionuclide, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-11 |
| Device Publish Date | 2025-08-01 |
| B16556530326033124037 | 15ga, 30 cm single leader catheters with colored button, 5/pack |
| B16556410326033124042 | 15ga single leader catheter with colored button, 5/pack |
| B16556450326083124107 | 15ga single leader catheter with colored button, 1/pack |
| B16556410326093024120 | 15ga single leader catheter with colored button, 5/pack |
| B16556410327073125152 | 15ga single leader catheter with colored button, 1/pack |