| Primary Device ID | 10615089311106 |
| NIH Device Record Key | 351dc985-5847-4de1-8b06-b853a21dc774 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HTP1500 |
| Version Model Number | HTPS1500 |
| Catalog Number | 3111-0001 |
| Company DUNS | 795104769 |
| Company Name | ADROIT MEDICAL SYSTEMS, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com | |
| Phone | 865-458-8600 |
| adroitmed@aol.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10615089311106 [Primary] |
| ILO | Pack, Hot Or Cold, Water Circulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-12-18 |
| Device Publish Date | 2019-10-04 |
| 10615089311106 | Accessory Rolling Stand for HTP1500 Pump |
| 10615089310109 | Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free |