| Primary Device ID | M68980100130 |
| NIH Device Record Key | 6764a5b5-d401-4426-ab20-12954504caa5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRAVENOUS INFUSION STARTER SET |
| Version Model Number | 13 |
| Catalog Number | 80-100 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68980100130 [Primary] |
| LRS | I.V. Start Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| M68980100110 | 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syr |
| M68980100120 | 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syr |
| M68980100130 | The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under th |
| M68980100140 | The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under th |