| Primary Device ID | 10615089310208 |
| NIH Device Record Key | dc7e36d6-6b41-4ae8-b360-d4e991f071a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surface Warming & Cooling System |
| Version Model Number | A3 |
| Catalog Number | 3102-0001 |
| 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 | true |
| Manufacturing Date | true |
| 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 | 10615089310208 [Primary] |
| ILO | Pack, Hot Or Cold, Water Circulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
| 10615089310147 - Accessory; HTP-1500 Replacement Cap | 2024-12-25 Replacement Black Cap for HTP-1500 |
| 20615089100301 - Soft-Temp | 2023-12-18 Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable. |
| 20615089100400 - Soft-Temp | 2023-12-18 Neck Pad, insulated, Velcro Fastener |
| 20615089100806 - Soft-Temp | 2023-12-18 Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in. |
| 20615089101001 - Soft-Temp | 2023-12-18 Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in. |
| 20615089101209 - Soft-Temp | 2023-12-18 Pad for Motorized Cold Therapy Knee Non-Sterile 12x12in. |
| 20615089101407 - Soft-Temp | 2023-12-18 Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in. |
| 20615089101704 - Soft-Temp | 2023-12-18 Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable |