| Primary Device ID | 00815067043378 |
| NIH Device Record Key | 82ff9cad-69a1-4212-86db-943975ebae8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MERIDIAN |
| Version Model Number | 4840-54 |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| 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 | true |
| Phone | 800-376-7263 |
| customerservice@compasshealthbrands.com | |
| Phone | 800-376-7263 |
| customerservice@compasshealthbrands.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815067043378 [Primary] |
| GS1 | 30815067043379 [Package] Package: CA [2 Units] In Commercial Distribution |
| 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 | 2019-08-20 |
| Device Publish Date | 2017-01-31 |
| 00815067043378 | 54'' APM BARIATRIC SYSTEM |
| 00815067042913 | Ultra Care Excel MRS System |
| 00815067042661 | 4581 |
| 00815067043798 | MER-SAPM PUMP - 8 LPM/350 LB CAP |
| 00815067043743 | MER-SAPM53 MATTRESS ONLY |
| 00815067043682 | MER-SAPM2 MATTRESS ONLY |