| Primary Device ID | 08511936007010 |
| NIH Device Record Key | f07378fd-724f-4581-ba48-201689a29021 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThermoSuit System |
| Version Model Number | TSP-50 Pump/Controller |
| Catalog Number | 75001 |
| Company DUNS | 825390458 |
| Company Name | LIFE RECOVERY SYSTEMS HD LLC |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08511936007010 [Direct Marking] |
| GS1 | 10851936007000 [Primary] |
| NZE | Hyperthermia Monitor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-12-18 |
| Device Publish Date | 2016-09-08 |
| 00851936007119 | Training Software |
| 00851936007102 | Pump/Controller Fill Hose |
| 00851936007096 | Temperature Cable |
| 00851936007089 | 18F Temperature Probe |
| 00851936007072 | Disposable Kit,Med. |
| 00851936007065 | Patch Kit |
| 00851936007058 | 12F Temperature Probe |
| 00851936007041 | Reservoir Liner |
| 00851936007034 | Top Sheet |
| 00851936007027 | Multi-lumen Umbilicus Hose |
| 00851936007010 | Pump Cassette Assembly |
| 00851936007003 | TSP-50 Pump/Controller |
| 00851936007126 | Activation Kit |
| 08511936007126 | Activation Kit |
| 10851936007079 | Disposable Kit, Case |
| 08511936007010 | TSP-50 Pump/Controller |