| Primary Device ID | 00850038863128 |
| NIH Device Record Key | 609fbcfa-2d73-4331-8dfe-29534c6b92cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HMG Distribution LLC |
| Version Model Number | CV1 |
| 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 | 00850038863128 [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 | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| 10850038863156 | 5” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors Bonded Needleless |
| 10850038863149 | 7” (18cm) Micro Bore Bifurcated Extension Set Bonded Needleless Connectors Bonded Needleless C |
| 10850038863132 | 7" (18cm) Macro Bore Extension Set Bonded Needleless Connector |
| 10850038863125 | Neutral Displacement Needleless Connector |
| 00850038863159 | 5” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors Bonded Needleless |
| 00850038863142 | 7” (18cm) Micro Bore Bifurcated Extension Set Bonded Needleless Connectors Bonded Needleless C |
| 00850038863135 | 7" (18cm) Macro Bore Extension Set Bonded Needleless Connector |
| 00850038863128 | Neutral Displacement Needleless Connector |