| Primary Device ID | 00817365022208 |
| NIH Device Record Key | 68d92a93-7433-4d65-9eba-c6ede5ab278d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion 2KXL |
| Version Model Number | FUS4284COV |
| Catalog Number | FUS4284COV |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com | |
| Phone | 314-771-5222 |
| info@moxiusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817365022208 [Primary] |
| FMW | Cover, Mattress (Medical Purposes) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-14 |
| Device Publish Date | 2022-11-04 |
| 00817365022215 | Fusion 2KXL Outer Cover 48x80x8 |
| 00817365022208 | Fusion 2KXL Outer Cover 42x84x8 |
| 00817365022192 | Fusion 2KXL Outer Cover 42x80x8 |