| Primary Device ID | 00817365020259 |
| NIH Device Record Key | 4ef92382-e215-4db1-a083-c6d5fef2a5e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion2K |
| Version Model Number | FUS2K80CA |
| Company DUNS | 958807575 |
| Company Name | MOXI ENTERPRISES, 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 | 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 | 00817365020259 [Primary] |
| FNM | Mattress, Air Flotation, Alternating Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-09 |
| 00817365020327 | FUSION SYSTEM - W/FULL LAL |
| 00817365020303 | FUSION 2K SYSTEM, CUSTOM SIZE |
| 00817365020297 | FUSION 2K CONVERSION KIT (FUSLAL2, SAHYBPUMP) |
| 00817365020280 | FUSION 2K SYSTEM 84" French Canadian |
| 00817365020273 | FUSION 2K SYSTEM 84" W/FR COVER |
| 00817365020266 | FUSION 2K SYSTEM 84" |
| 00817365020259 | FUSION 2K SYSTEM 80" French Canadian |
| 00817365020242 | FUSION 2K SYSTEM 80" |
| 00817365020235 | FUSION 2K SYSTEM 39x80" |