| Primary Device ID | 10884521713000 |
| NIH Device Record Key | c2bd6b12-1e4f-492e-b287-4022be27def5 |
| Commercial Distribution Discontinuation | 2016-09-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ZephyrLIFE Home |
| Version Model Number | 9607.0259 |
| Catalog Number | 9607.0259 |
| Company DUNS | 796678527 |
| Company Name | ZEPHYR TECHNOLOGY LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521713000 [Primary] |
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-11-13 |
| Device Publish Date | 2016-09-24 |
| 10884521712928 | ZL Home Kit - A |
| 10884521712911 | ZL Home Kit - Demo |
| 10884521713000 | ZL Home Kit - J |
| 10884521712959 | ZL Home Kit - D |
| 10884521712997 | ZL Home Kit - H |
| 10884521712980 | ZL Home Kit - G |
| 10884521712973 | ZL Home Kit - F |
| 10884521712966 | ZL Home Kit - E |
| 10884521712942 | ZL Home Kit - C |
| 10884521712935 | ZL Home Kit - B |
| 10884521712898 | ZephyrLIFE Home HealthHub Patient Software Application? |