| Primary Device ID | 00853360007147 |
| NIH Device Record Key | 4fcfd316-4aa6-4c96-adaf-33e2ec03bd87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Völkner® Turning System |
| Version Model Number | PANDA III 54" Bariatric Mattress Replacement 84" |
| Company DUNS | 183085083 |
| Company Name | JAMES CONSOLIDATED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853360007147 [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 | 3 |
| Public Version Date | 2019-05-01 |
| Device Publish Date | 2016-11-18 |
| 00853360007147 | PANDA III 54" Bariatric Mattress Replacement 84" |
| 00853360007130 | PANDA III 48" Bariatric Mattress Replacement 84" |
| 00853360007123 | MARK II Mattress Replacement 84" Special Producti |
| 00853360007116 | MARK I Mattress Overlay 84" Special Production |
| 00853360007109 | EUROPA I Mattress Overlay 84" Special Production |
| 00853360007093 | BETA II Mattress Replacement 84" Special Productio |
| 00853360007086 | BETA I Mattress Overlay 84" Special Production |
| 00853360007079 | PANDA III 54" Bariatric Mattress Replacement |
| 00853360007062 | PANDA III 48" Bariatric Mattress Replacement |
| 00853360007048 | EUROPA I Mattress Overlay |
| 00853360007031 | MARK II Mattress Replacement |
| 00853360007024 | MARK I Mattress Overlay |
| 00853360007017 | BETA II Mattress Replacement |
| 00853360007000 | BETA I Mattress Overlay |