| Primary Device ID | 10850038863200 |
| NIH Device Record Key | 1cf7b5c3-d80c-499f-a430-707792a00b86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Directmed, Inc. |
| Version Model Number | DM-116 |
| Company DUNS | 969484237 |
| Company Name | Directmed, Inc. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10850038863200 [Primary] |
| FPA | Set, Administration, 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 | 2025-07-21 |
| Device Publish Date | 2025-07-11 |
| 10850038863118 | EXTENSION SET 7" SMALLBORE |
| 10850038863101 | EXTENSION SET 7” SMALLBORE BONDED VALVE |
| 00850038863111 | EXTENSION SET 7" SMALLBORE |
| 00850038863104 | EXTENSION SET 7” SMALLBORE BONDED VALVE |
| 10850038863163 | Extension Set with 0.2um filter |
| 00850038863166 | Extension Set with 0.2um filter |
| 10850038863170 | Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile |
| 00850038863173 | Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile |
| 10850038863200 | Transfer Set |
| 00850038863203 | Transfer Set |