| Primary Device ID | 00811331011562 |
| NIH Device Record Key | 9d938c3f-9eab-49ef-bc68-badd5a30bdbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3-Lead LTE MCT Monitor ZOLL |
| Version Model Number | H3R-0161 |
| Company DUNS | 793149709 |
| Company Name | Tz Medical, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811331011562 [Primary] |
| DSI | Detector And Alarm, Arrhythmia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-28 |
| Device Publish Date | 2023-09-20 |
| 00811331011470 - ARC Adjustable Radial Cuff | 2023-11-23 ARC Adjustable Radial Cuff- Large |
| 00811331011333 - ARC Adjustable Radial Cuff | 2023-11-23 ARC Adjustable Radial Cuff- Small |
| 00811331013917 - H3R USB Cable | 2023-11-23 H3R USB Cable |
| 00811331013931 - H3R Holster | 2023-11-23 H3R Holster (Rev A) |
| 00811331013245 - TZ Medical Pressure Discs | 2023-10-30 Round Universal Disc |
| 00811331011210 - EZ Holder | 2023-10-30 EZ Holder |
| 00811331011647 - TruBrite Adhesive Retractor Light | 2023-10-30 Adhesive Retractor Light |
| 00811331011715 - TZ Medical Pressure Discs | 2023-10-30 Oval Universal Disc |