| Primary Device ID | 00850045714406 |
| NIH Device Record Key | fb33b851-ce0e-46aa-94d7-0ebb8dd303b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soteria Mattress Barrier |
| Version Model Number | Universal Stretcher UNVST5-0000 |
| Company DUNS | 078444470 |
| Company Name | Trinity Guardion, 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 | 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 | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com | |
| Phone | 812-932-2600 |
| info@trinityguardion.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850045714406 [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 | 2024-10-29 |
| Device Publish Date | 2024-10-21 |
| 00850045714406 | 5" Version |
| 00850045714451 | Universal 75x38x6 753806-000S |
| 00850045714475 | Universal Stretcher STRU30-0000 |
| 00850045714468 | Universal Stretcher STRU26-0000 |
| 00850045714482 | Universal 80x48x9 804809-A00S |
| 00850045714505 | Gynnie Stretcher Foot STRGYN-000F |
| 00850045714499 | Gynnie Stretcher Head STRGYN-000H |