| Primary Device ID | 00850048235007 |
| NIH Device Record Key | 8e910edd-4dde-4588-9d58-a83bb99e92be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HMG |
| Version Model Number | 001 |
| Company DUNS | 117654675 |
| Company Name | Hartman Medical Group LLC |
| Device Count | 50 |
| 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 | true |
| 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 | 00850048235007 [Primary] |
| GS1 | 00850048235038 [Unit of Use] |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| 10850048235004 | Electrode, Electrocardiograph-40 Pouches of 50 |
| 00850048235007 | Electrode, electrocardiograph-Pouch of 50 |
| 00850048235021 | Blood Collection Device-Female Luer Adapter |
| 00850048235014 | Blood Collection Device-Male Luer Adapter |
| 00850048235052 | Macro Bore IV extension set with Needle less Y-site and removable needless connector |