| Primary Device ID | 00863220000416 |
| NIH Device Record Key | 5aa832e6-ac9d-44d2-bf63-4da176103031 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unisoft |
| Version Model Number | UO-SPUM-800 |
| Catalog Number | UO-SPUM-800 |
| Company DUNS | 117050858 |
| Company Name | Unisoft Medical Corporation |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| 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 | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com | |
| Phone | 8604826848 |
| inquiry@unisoftmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863220000416 [Primary] |
| FNM | Mattress, Air Flotation, Alternating Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00863220000416 | Unisoft ONE Single Patient Use Alternating Pressure Mattress |
| 00863220000409 | Unisoft ONE Single Patient Use Therapeutic Support System |