| Primary Device ID | 00850045714369 |
| NIH Device Record Key | cbff792a-0142-4c0e-bd1d-e2e364b51eea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soteria Pediatric Mattress Barrier |
| Version Model Number | Giraffe Standard GIRSTD-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 | |
| 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 | 00850045714369 [Primary] |
| GS1 | 00850045714376 [Package] Package: Dispenser Box [10 Units] In Commercial Distribution |
| GS1 | 00850045714383 [Package] Contains: 00850045714376 Package: Shipping Carton - 20 [2 Units] In Commercial Distribution |
| GS1 | 00850045714390 [Package] Contains: 00850045714376 Package: Shipping Carton - 40 [4 Units] In Commercial Distribution |
| 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 | 2024-05-21 |
| Device Publish Date | 2024-05-13 |
| 00850045714369 | Giraffe Standard GIRSTD-0000 |
| 00850045714321 | Universal Pediatric 26191X-0000 |